Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical instrument failure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Biomet U.K., Ltd. is conducting a medical device field action for specific lots of Oxford Partial Knee System instruments. The affected products are the Oxford Partial Knee System Left Medial Tibial Trial Tray Size A, with a total of 72 units involved.
The recall is due to potential alumina inclusions in the raw material batch used to produce these instruments. These inclusions could lead to the cracking and separation of the instrument during use. The affected lots are ZB160501, ZB160701, and ZB160702, under item number 32-420820.
The products were distributed worldwide, including in the United States states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, and NJ, as well as in Thailand, Japan, and the Netherlands. Healthcare providers and facilities should stop using the affected instruments and contact Biomet for further instructions.
The recalled product
- Product
- Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
- Manufacturer
- Biomet U.K., Ltd.
- Affected units
- 72
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Item: 32-420820
- Lots: ZB160501
- ZB160701
- ZB160702
Distribution
Part of a larger recall action
This product is one of 24 recalled by Biomet U.K., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 24 products in this recall →Related recalls
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