FDA (Devices) recall action 76179
The FDA (Devices) publishes a recall like this one as 24 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 24 pages.
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Biomet is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Knee System Tibial Resector Body Tubes and Guides due to potential alumina inclusions that could cause the instruments to crack or separate.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System Femoral Slap Hammers due to potential alumina inclusions that could cause the instruments to crack or separate.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K. is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet is recalling Oxford Knee instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Knee instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Knee instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K. is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Partial Knee System trial trays due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Unicompartmental Knee Phase 3 Shim Size 3 instruments due to potential alumina inclusions that could cause cracking and separation.
Biomet U.K., Ltd. is recalling Oxford Unicompartmental Knee Phase 3 Shim Size 1 instruments due to potential alumina inclusions that could cause cracking and separation.