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.
Notes supplémentaires dans les données
ligament staple impactor - Product Code HXJ
Cause
The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles.
Action
Customer recall notifications included:
a) Telephone notification to highest volume users
b) Recall letters were sent via certified mail to all customers June 1, 2006.
Customers were instructed to cease using immediately and return the Impactors to Tapco. The customers were instructed to call the firm for a return authorization number. Modified loaner Impactors will be made available to customers as soon as possible.
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.
Notes supplémentaires dans les données
ligament staple impactor - Product Code HXJ
Cause
The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles.
Action
Customer recall notifications included:
a) Telephone notification to highest volume users
b) Recall letters were sent via certified mail to all customers June 1, 2006.
Customers were instructed to cease using immediately and return the Impactors to Tapco. The customers were instructed to call the firm for a return authorization number. Modified loaner Impactors will be made available to customers as soon as possible.
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.
Notes supplémentaires dans les données
Shoulder system, reverse - Product Code KWT
Cause
Components may not lock together as intended.
Action
Consignees were notified via recall letter dated 7/20/06 to cease use of the products and to return the product to Zimmer.
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.
Notes supplémentaires dans les données
Shoulder system, reverse - Product Code KWT
Cause
Components may not lock together as intended.
Action
Consignees were notified via recall letter dated 7/20/06 to cease use of the products and to return the product to Zimmer.
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.
Notes supplémentaires dans les données
Shoulder System - Product Code KWT
Cause
Components may not lock together as intended.
Action
Consignees were notified via recall letter dated 7/20/06 to cease use of the products and to return the product to Zimmer.
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.
Notes supplémentaires dans les données
Tibial Punch - Product Code LXH
Cause
Tibial punches were not manufactured to specification and could break at the tip during use.
Action
Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email and telephone follow-up) on 08/29/2006 to request the return of any in stock product.
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.
Notes supplémentaires dans les données
Tibial Tray - Product Code JWH
Cause
Improperly machined parts: the cemented finned tibial trays could not seat the size 2 mating trial or polyethylene insert.
Action
The recall was initiated on August 31, 2006. The distributors were notified by FAX, email and telephone. The returned devices will be stored quarantine.
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.
Notes supplémentaires dans les données
Drill Bit - Product Code HTW
Cause
Incorrect drill length-cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the uni-clip staple.
Action
An Urgent Recall Notice was sent on 11/10/2006 to both hospitals/distributors and sales representatives by first class mail.
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.
Notes supplémentaires dans les données
Bone Cement - Product Code MBB
Cause
The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. the external label provides for an incorrect longer expiration date than the actual subcomponents will support.
Action
A recall notification was sent by Federal Express on 11/7/06. The firm will follow-up with telephone calls and follow-up letters as necessary.
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.
Notes supplémentaires dans les données
Hip Stem - Product Code KWL
Cause
Lack of assurance of sterility (package integrity): anomalies in seal width and strength that may affect the integrity of the sterile barrier.
Action
Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.