Biomet Recalls Oxford Knee Instruments Due to Material Inclusions
Biomet 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 Knee instruments. The affected products are Oxford Partial Knee System Right Medial Tibial Trial Tray Size A instruments, which are used with the Oxford Uni Partial Knee System.
The recall is due to potential alumina inclusions in the raw material batch used to produce these products. These inclusions could lead to the cracking and separation of the instrument during use.
A total of 72 units are affected. The products were distributed worldwide, including in the US states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, and OK, as well as in Thailand, Japan, and the Netherlands. The specific item number is 32-420821, and the affected lot numbers are ZB160601 and ZB160701.
The recalled product
- Product
- Oxford Partial Knee System Right 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 (3)
- Item: 32-420821
- Lots: 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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See all →- HighBiomet Oxford Knee Instruments Recalled for Material Inclusions
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- HighBiomet Oxford Partial Knee Instruments Recalled for Material Inclusions
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- HighBiomet Recalls Oxford Knee Instruments Due to Material Inclusions
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