Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions
Biomet is recalling Oxford Partial Knee 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 (surgical 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 instruments. The affected products are the Oxford Partial Knee System Right Medial Tibial Trial Tray Size D, with item number 32-420735. The recall covers 72 units from lots ZB160501, ZB160601, and ZB160801.
The recall is being conducted because of potential alumina inclusions in the raw material batch used to produce these instruments. These inclusions could lead to the cracking and separation of the finished product. The affected instruments were distributed worldwide, including in the United States states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, and OK, as well as in Thailand, Japan, and the Netherlands.
Healthcare providers and facilities that have received these specific instruments should stop using them and contact Biomet for further instructions. Consumers are not directly affected as these are surgical instruments used by medical professionals.
The recalled product
- Product
- Oxford Partial Knee System Right Medial Tibial Trial Tray Size D 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: 32-420735
- Lots: ZB160501
- ZB160601
- ZB160801
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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