FDA-Device2017-03-01Class II
Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Biomet U.K., Ltd.
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.
Sold states
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
Affected count
72 units in total
Manufactured in
Waterton Industrial Estate, N/A, Bridgend South Wales, N/A, United Kingdom
Products
Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1158-2017Don't want to check this manually?
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