Reported Mar 1, 2017 · Terminated

Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni…

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 Partial Knee System Right Medial
  • Tibial Trial Tray Size A Product UsageInstruments for use with the Oxford Uni Partial Knee System
Lot codes and dates
  • Item32-420821
  • Lots
    • ZB160601
    • ZB160701
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 30, 2018 · Data as of Sep 19, 6:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.