medical MODERATE Updated 2017-03-01

Biomet U.K., Ltd. recalls Oxford Unicompartmental Knee Phase 3 Tibial Impactor Produc

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Recalled Product

Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni Partial Knee System

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Hazard / Issue

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.

Issued by

FDA

Affected States: LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ
Lot/Code Info: Item: 32-420932, Lots: ZB160801, ZB160802, ZB160803

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall