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
spinal implant component - Product Code KWQ
Causa
Surgeons may apply an accidental axial torque to and/or over-angulate the all-in one guide while implanting the screw. this may cause the screw not to seat properly in the locking ring and may cause the thor screwdrivers to twist or break at the tip.
Acción
Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.
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
spinal implant component - Product Code KWQ
Causa
Surgeons may apply an accidental axial torque to and/or over-angulate the all-in one guide while implanting the screw. this may cause the screw not to seat properly in the locking ring and may cause the thor screwdrivers to twist or break at the tip.
Acción
Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.
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
spinal implant component - Product Code KWQ
Causa
Surgeons may apply an accidental axial torque to and/or over-angulate the all-in one guide while implanting the screw. this may cause the screw not to seat properly in the locking ring and may cause the thor screwdrivers to twist or break at the tip.
Acción
Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.
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
spinal implant component - Product Code KWQ
Causa
Surgeons may apply an accidental axial torque to and/or over-angulate the all-in one guide while implanting the screw. this may cause the screw not to seat properly in the locking ring and may cause the thor screwdrivers to twist or break at the tip.
Acción
Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.
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
spinal implant component - Product Code KWQ
Causa
Surgeons may apply an accidental axial torque to and/or over-angulate the all-in one guide while implanting the screw. this may cause the screw not to seat properly in the locking ring and may cause the thor screwdrivers to twist or break at the tip.
Acción
Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.
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
spinal implant component - Product Code KWQ
Causa
Surgeons may apply an accidental axial torque to and/or over-angulate the all-in one guide while implanting the screw. this may cause the screw not to seat properly in the locking ring and may cause the thor screwdrivers to twist or break at the tip.
Acción
Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.
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
ACCESSORIES, ARTHROSCOPIC - Product Code NBH
Causa
Device may have improper laser marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.
Acción
A notification letter was issued via Fedex on September 3, 2009 to domestic consignees and international consignees were notified via e-mail. The letter described the issue as the affected device may have improper laser marking. The 4mm devices are marked as 6mm and the 6mm devices are marked at 4mm. Customers were instructed to return the completed response form and affected product in inventory to Smith & Nephew. Direct questions about the recall to your local Smith & Nephew Sales Representatives or call 1-508-261-3655.
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
ACCESSORIES, ARTHROSCOPIC - Product Code NBH
Causa
Device may have improper laser marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.
Acción
A notification letter was issued via Fedex on September 3, 2009 to domestic consignees and international consignees were notified via e-mail. The letter described the issue as the affected device may have improper laser marking. The 4mm devices are marked as 6mm and the 6mm devices are marked at 4mm. Customers were instructed to return the completed response form and affected product in inventory to Smith & Nephew. Direct questions about the recall to your local Smith & Nephew Sales Representatives or call 1-508-261-3655.
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
Screw, fixation, bone - Product Code HWC
Causa
Biomet microfixation is recalling lactosorb self drilling adjustable tap model numbers 915-2075 lot # 064350 and 915-2185 lot # 885580. the two lots identified have a new style stop and an old style tap; they are not compatible, as the depth etchings do not line up correctly. depending on the tap (1.5mm vs 2.0mm) you may drill too shallow or too deep.
Acción
Biomet Microfixation notified consignees of the recalled product beginning September 2009 via telephone and e-mail correspondence. Users were asked to return the affected product to the firm.
For further information, contact Biomet Microfixation at 1-904-741-9468.
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
Screw, fixation, bone - Product Code HWC
Causa
Biomet microfixation is recalling lactosorb self drilling adjustable tap model numbers 915-2075 lot # 064350 and 915-2185 lot # 885580. the two lots identified have a new style stop and an old style tap; they are not compatible, as the depth etchings do not line up correctly. depending on the tap (1.5mm vs 2.0mm) you may drill too shallow or too deep.
Acción
Biomet Microfixation notified consignees of the recalled product beginning September 2009 via telephone and e-mail correspondence. Users were asked to return the affected product to the firm.
For further information, contact Biomet Microfixation at 1-904-741-9468.
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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Causa
The threaded tip of the reflex hybrid screw extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.
Acción
An "Urgent Product Recall" letter was sent to Stryker Branches/Agencies on October 12, 2009 and to surgeons who have used the device on October 26, 2009. The recall letter described the affected products, issue and potential hazards. Consignees were instructed to examine their inventory and hospital locations for the affected products and return to Stryker Spine as indicated in the recall letter. Customers were also instructed to complete the enclosed Customer Response form and fax to 1-201-760-8370.
Direct questions about the recall to Stryker Spine by calling 1-201-760-8206.
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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
Causa
The threaded tip of the reflex hybrid screw extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.
Acción
An "Urgent Product Recall" letter was sent to Stryker Branches/Agencies on October 12, 2009 and to surgeons who have used the device on October 26, 2009. The recall letter described the affected products, issue and potential hazards. Consignees were instructed to examine their inventory and hospital locations for the affected products and return to Stryker Spine as indicated in the recall letter. Customers were also instructed to complete the enclosed Customer Response form and fax to 1-201-760-8370.
Direct questions about the recall to Stryker Spine by calling 1-201-760-8206.
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
Drill Bit - Product Code HTW
Causa
The epoxy is flaking off the drill bits and countersinks.
Acción
On 9/3/2009 the firm sent letters to their customers requesting return of all recalled product in stock and for those products to be replaced with the ones listed in the letter. Questions should be directed to 330-869-0625.
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 adapters are able to come apart when a retaining ring in the proximal end of the adapter can dislodge from the retaining ring groove and the two ends of the adapter fall apart and are unable to be reassembled without special tools and knowledge of the instrument.
also the adapters have a wobble between the two ends. this is caused when the distal and proximal ends of the adapter assembly were.
Acción
Two "IMPORTANT RECALL NOTICE" letters, one dated October 16, 2009, and the second letter dated November 19, 2009, were sent to the customers. The letters described the product, problem and action to be taken by the customers. The customer are requested to discontinue use of the adapters and return them to the firm, Orthohelix Surgical Designs. The firm will replace the adapters as soon as possible.
Should you have any questions about the systems please contact Kristin Wolff at 330-247-1445 or Jim Bragg at 330-247-1444.
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.
Medacta usa inc is initiating a recall on the femoral sizer, an orthopedic manual surgical instrument, because the "l" and "r" markings are mislabeled which would cause incorrect usage.
Acción
The firm, Medacta USA Inc, sent an "Urgent Safety Notification" letter dated August 5, 2009, to the customers. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to check their inventory for devices listed, if found, to immediately sequester them and DO NOT use them in surgery. The customers were ask to please pack the affected femoral sizer(s) posterior reference for shipment to Medacta USA. Medacta informed the customers that Medacta USA personnel will contact them by telephone to provide them with an RMA number and the reworked femoral sizer(s) posterior reference will be returned as soon as they are available.
If you have any questions, please feel free to contact the Medacta USA office at 805-437-7085 or contact Ms. Heather Neely directly at 805-886-1069.
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 results of an investigation into complaints revealed that trabecular metal humeral and/or zimmer¿ trabecular metal reverse humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.
Acción
Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:
a. provide the Dear Surgeon (Urgent Device Correction) letter and revised
surgical technique directly to surgeons and risk managers at facilities using
the device or
b. provide a list of facilities and surgeons using the TM Humeral and TM
Reverse shoulder systems to the Zimmer Recall Coordinator, and
c. destroy previous versions of the surgical technique, and
d. inform users of when the new surgical technique, instrument case, distal
reamers, and distal pilots will be shipped to them based on communication
from Zimmer, Inc.
Handling of returned product:
HCPs were notified to return all of the distal pilots in the scope back to
Zimmer which were to be be destroyed once the recall has been completed. They will
also be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the
Bigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by
Zimmer Sales Representatives.
For questions regarding this recall call (574) 371-8852.
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 results of an investigation into complaints revealed that trabecular metal humeral and/or zimmer¿ trabecular metal reverse humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.
Acción
Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:
a. provide the Dear Surgeon (Urgent Device Correction) letter and revised
surgical technique directly to surgeons and risk managers at facilities using
the device or
b. provide a list of facilities and surgeons using the TM Humeral and TM
Reverse shoulder systems to the Zimmer Recall Coordinator, and
c. destroy previous versions of the surgical technique, and
d. inform users of when the new surgical technique, instrument case, distal
reamers, and distal pilots will be shipped to them based on communication
from Zimmer, Inc.
Handling of returned product:
HCPs were notified to return all of the distal pilots in the scope back to
Zimmer which were to be be destroyed once the recall has been completed. They will
also be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the
Bigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by
Zimmer Sales Representatives.
For questions regarding this recall call (574) 371-8852.
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 results of an investigation into complaints revealed that trabecular metal humeral and/or zimmer¿ trabecular metal reverse humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.
Acción
Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:
a. provide the Dear Surgeon (Urgent Device Correction) letter and revised
surgical technique directly to surgeons and risk managers at facilities using
the device or
b. provide a list of facilities and surgeons using the TM Humeral and TM
Reverse shoulder systems to the Zimmer Recall Coordinator, and
c. destroy previous versions of the surgical technique, and
d. inform users of when the new surgical technique, instrument case, distal
reamers, and distal pilots will be shipped to them based on communication
from Zimmer, Inc.
Handling of returned product:
HCPs were notified to return all of the distal pilots in the scope back to
Zimmer which were to be be destroyed once the recall has been completed. They will
also be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the
Bigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by
Zimmer Sales Representatives.
For questions regarding this recall call (574) 371-8852.
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 results of an investigation into complaints revealed that trabecular metal humeral and/or zimmer¿ trabecular metal reverse humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.
Acción
Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:
a. provide the Dear Surgeon (Urgent Device Correction) letter and revised
surgical technique directly to surgeons and risk managers at facilities using
the device or
b. provide a list of facilities and surgeons using the TM Humeral and TM
Reverse shoulder systems to the Zimmer Recall Coordinator, and
c. destroy previous versions of the surgical technique, and
d. inform users of when the new surgical technique, instrument case, distal
reamers, and distal pilots will be shipped to them based on communication
from Zimmer, Inc.
Handling of returned product:
HCPs were notified to return all of the distal pilots in the scope back to
Zimmer which were to be be destroyed once the recall has been completed. They will
also be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the
Bigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by
Zimmer Sales Representatives.
For questions regarding this recall call (574) 371-8852.
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 results of an investigation into complaints revealed that trabecular metal humeral and/or zimmer¿ trabecular metal reverse humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.
Acción
Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:
a. provide the Dear Surgeon (Urgent Device Correction) letter and revised
surgical technique directly to surgeons and risk managers at facilities using
the device or
b. provide a list of facilities and surgeons using the TM Humeral and TM
Reverse shoulder systems to the Zimmer Recall Coordinator, and
c. destroy previous versions of the surgical technique, and
d. inform users of when the new surgical technique, instrument case, distal
reamers, and distal pilots will be shipped to them based on communication
from Zimmer, Inc.
Handling of returned product:
HCPs were notified to return all of the distal pilots in the scope back to
Zimmer which were to be be destroyed once the recall has been completed. They will
also be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the
Bigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by
Zimmer Sales Representatives.
For questions regarding this recall call (574) 371-8852.
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 results of an investigation into complaints revealed that trabecular metal humeral and/or zimmer¿ trabecular metal reverse humeral implants engaging in the canal earlier than expected could lead to incomplete seating of the implant, delay in surgery, humeral fracture, or the need for cement in a press-fit application.
Acción
Zimmer, Inc. sent an URGENT DEVICE CORRECTION letter dated September 10, 2010 to surgeons, risk managers, and distributors. The letter identified the product, the problem, and the action to be taken. Sales Representatives were instructed to:
a. provide the Dear Surgeon (Urgent Device Correction) letter and revised
surgical technique directly to surgeons and risk managers at facilities using
the device or
b. provide a list of facilities and surgeons using the TM Humeral and TM
Reverse shoulder systems to the Zimmer Recall Coordinator, and
c. destroy previous versions of the surgical technique, and
d. inform users of when the new surgical technique, instrument case, distal
reamers, and distal pilots will be shipped to them based on communication
from Zimmer, Inc.
Handling of returned product:
HCPs were notified to return all of the distal pilots in the scope back to
Zimmer which were to be be destroyed once the recall has been completed. They will
also be instructed to either return the reamers back to Zimmer or to remove these reamers from the TM Reverse shoulder systems sets and place into the
Bigliani/Flatow Complete Shoulder Solution set. New surgical techniques will also be introduced and the user will be asked to remove previous versions of the surgical technique from all points of use. This removal will be verified by
Zimmer Sales Representatives.
For questions regarding this recall call (574) 371-8852.
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.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
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.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
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.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.
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.
Potential for out of specification star grind teeth.
Acción
Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time.
Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number.
Return the Verification Form with the recalled product to:
Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132.
For questions regarding this recall call 1-800-620-7025, x 6883.