U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notas adicionales en la data
Surgical Graft - Product Code FTM
Causa
Davol cannot guarantee that all xenomatic product released from july to october 2010 meets fda guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria.
Acción
Davol issued recall notification to accounts by letter dated 1/06/11 requesting recalled units be returned. contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product to Davol. A fax sheet attached to the letter to be completed and fax to 1-401-825-8753.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports.
depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
Acción
DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices.
Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit.
Patients with radiographic changes indicative of product failure should be addressed according to normal procedures.
All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts.
Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols.
For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.:
" Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans.
" If metal ion levels in whole blood are elevated above 7 parts per billion (ppb) for either metal ion, a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging
" If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses, then revision surgery should be considered.
DePuy representatives were to assist with returns of any remaining inventory.
For questions regarding this recall call 574-372-7333.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The firm identified that a component within the system 1 abd and occluder modules that may malfunction. the air bubble detector module (abd) is used with an air sensor to detect gross air bubbles in the perfusion circuit. the occluder module is used with the occluder head to provide a computer controlled tube clamping mechanism to regulate the flow in the venous line.
the firm identified a fai.
Acción
Terumo Cardiovascular Systems Corporation issued an URGENT MEDICAL DEVICE CORRECTION letter dated 12/2/2010 to the Director of Cardiac Operating Room Services or Operating Room Nurse Manager. The letter identified the product, the problem, and the action to be taken. The letter stated the firm will replace all modules in the affected population, and that a representative would contact the consignee regarding the replacement schedule.
Customers were to review the Medical Device Correction.
Assure that all user were aware of the notice.
Confirm receipt of the communication by faxing the attached Customer Response Form to the fax number indicated on the form.
For questions regarding this recall call 1-800-521-2818.