Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1173-2017 — Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System

U.S. FDA — Device Enforcement · United Kingdom · 2016-01-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1173-2017
Date of alert
2016-01-05
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
Biomet U.K., Ltd.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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