Biomet Oxford Knee Instruments Recalled for Potential 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 is classified as FDA Class II. The hazard involves potential cracking and separation of surgical instruments, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Biomet U.K., Ltd. is conducting a medical device field action for specific lots of Oxford Knee instruments. The recall involves the Oxford Partial Knee System Left Medial Tibial Trial Tray Size E, with 72 units in total affected.
The action is being taken because the raw material batch used to produce these products may contain alumina inclusions. These inclusions could lead to the cracking and separation of the finished instruments.
The affected products 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. The specific item number is 32-420736, and the affected lot numbers are ZB160501 and ZB160601. Users should stop using these instruments and contact the manufacturer for further instructions.
The recalled product
- Product
- Oxford Partial Knee System Left Medial Tibial Trial Tray Size E 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: 32-420736
- Lots: ZB160501
- ZB160601
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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