Reported Mar 1, 2017 · Terminated
Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the Oxford Uni Partial Knee…
Biomet U.K., Ltd.
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: Biomet U.K., Ltd. · Waterton Industrial Estate · Bridgend South Wales, N/A · N/A
Is this the product you have?
- Oxford Unicompartmental
- Knee Phase 3 Shim Size 2 Product UsageInstruments for use with the Oxford Uni Partial Knee System
- Lot codes and dates
- Item32-420664
- Lots
ZB160601ZB160701
- Amount recalled
- 72 units in total
This recall covers 24 products
The agency filed one notice per product. You are reading one of them; the other 23 are below.
11 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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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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