Reported Apr 26, 2017 · Terminated
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform
- Biomet CP Bearings Product UsageFor use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement
- Lot codes and dates
293 of 293 products
Products covered by this recall Model / number Product as published 141261598890 141262501720 781540 141263466300 516170 516190 141264466430 516220 516230 516240 584590 609910 141265466440 527490 609920 684740 141266584620 141268527590 141481412820 920390 141482289810 412870 805950 920410 141483537790 141484412920 903910 141485920420 141512781920 781960 805970 141514806010 141515827960 150410241990 373830 596750 150411231200 373840 373850 150412129940 231210 231220 596910 150413129950 150414409730 - Amount recalled
- 28,253 in total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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