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 anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
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 anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
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 anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
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 anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
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 anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
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 anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
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 anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
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 anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
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 anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
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 anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
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 anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
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 anspach effort, inc. is recalling all lots of the anspach micro curved attachment (mca) cutting burrs and dissection tools. the recall was initiated after the indications for use were found to be broader than the validation of the mca cutting burrs and its directions for use did not clearly state the correct intended use of the device. after a labeling correction, anspach effort, inc. decide.
Acción
Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium., viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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
Causa
Products shipped to us locations that do not have approved applications for pma , ide or 510(k) clearance.
Acción
Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.
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.
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. viper large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.
Acción
DePuy Synthes Spine sent an Urgent Voluntary Product Recall Notification letter dated November 7, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine the material and return remaining inventory. Customers were advised to complete the enclosed Business Reply Form and fax back to 508-828-3762 or email to lregan3@its.jnj.com. For questions call Linda Regan @508-977-6606.
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
Introducer, catheter - Product Code DYB
Causa
Greatbatch medical observed some anomalies of the inner lumen of the mobicath bi-directional guiding sheaths upon implementation of a new visual inspection tool. the anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen).
Acción
Biosense Webster sent an "Urgent Field Safety Notice" dated November 12, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Voluntary Field Removal Certification Form was attached for customers to complete and return. Contact the firm at 800-729-9010 for questions related to this issue.
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.
It has been determined that cobas b 123 fluid pack coox cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. internal investigations found the altered thickness of the cuvette was due to production equipment settings. cuvettes were produced within specifications, but within the upper.
Acción
Roche sent an Urgent Medical Device Removal (UMDR12-268) notification and faxback form on November 14, 2012, to all affected consignees. Customers were requested to discontinue the use of cobas b 123 Fluid Pack COOX, 200 lots 21426121 and21426171 and discard the product per local regulations. Customers were instructed to use the enclosed faxback form to order replacement product at 1-800-722-7222. For questions customers were instructed to contact Roche Diagnostics Technical Support at 1-800-526-2272.
For questions regarding this recall call 317-521-3966.
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
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Causa
Zimmer spine has received reports of the peek ardis interbody spacer breaking into fragments when too much lateral force is applied to the ardis inserter. if the peek ardis interbody spacer breaks during implantation, surgical delays of up to 60 minutes could occur. sharp edges of the broken implant may contact and damage adjacent structures, requiring surgical intervention. observed health risks.
Acción
Zimmer Spine, sent a "MEDICAL DEVICE CORRECTION" memo dated November 12, 2012 to all consignees / customers describing product, problem and actions to be taken including revised surgical technique. Beginning the week of December 17, 2012, Zimmer began the immediate retrieval of the affected units as a Class I recall. December 20, 2012 nation wide press outlining the recall was issued. Customers may report adverse events or quality problems experienced with the use of these products to Zimmer Spine by calling 866-774-6368 between the hours of 8AM and 5PM CST or by email at qualitycompliance@zimmer.com.