Biomet Oxford Knee Instruments Recalled for Material Inclusions
Biomet is recalling Oxford 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 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 recall involves 72 units of the Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B, identified by Item 32-420056 and Lot ZB160701.
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 instruments during use.
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. Healthcare providers and facilities should stop using the affected instruments and contact Biomet for further instructions.
The recalled product
- Product
- Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B 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:32-420056
- Lots: 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
Same manufacturer · Biomet U.K., Ltd.
See all →- HighBiomet Oxford Knee Instruments Recalled for Material Inclusions
FDA (Devices) · 2017-03-01
- HighBiomet Oxford Knee Instruments Recalled for Potential Material Inclusions
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- HighBiomet Recalls Oxford Knee Instruments Due to Material Inclusions
FDA (Devices) · 2017-03-01
- HighBiomet Oxford Partial Knee Instruments Recalled for Material Inclusions
FDA (Devices) · 2017-03-01
- HighBiomet Recalls Oxford Knee Instruments Due to Material Inclusions
FDA (Devices) · 2017-03-01
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