FDAFDA · Food and drugs·Recall number Z-1157-2017
Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Published March 1, 2017 · Recall initiated: January 5, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet U.K., Ltd.
- Distributor
- Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, JAPAN, NETHERLANDS
- Lot
- Item: 32-420822, Lots: ZB160501 ZB160601 ZB160701
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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