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Recall Observatory FDA recall evidence

Device product

Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Z-1169-2017

January 05, 2016

Class II

Product summary

Firm
Biomet U.K., Ltd.
Event
Event 76179
Status
Terminated
Classification
Class II
Quantity
72 units in total
Official record key
device-enforcement:Z-1169-2017

Official wording

Reason: 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.

Code information: Item:32-420664, Lots: ZB160601, ZB160701

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.