Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions
Biomet U.K. 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 (medical instrument) where injury has not yet been reported, fitting the High severity criteria for potential cracking and separation.
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 F, which are instruments used with the Oxford Uni Partial Knee System. A total of 72 units are involved in this action.
The recall is being conducted because the raw material batch used to produce these instruments may contain alumina inclusions. These inclusions could lead to the cracking and separation of the finished instrument during use. The affected items are identified by Item 32-420823 and Lots ZB160501, ZB160601, and ZB160701.
The affected instruments 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 Right Medial Tibial Trial Tray Size F 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 (2)
- Item: 32-420823
- Lots: ZB160501 ZB160601 ZB160701
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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