Biomet Recalls Oxford Knee Instruments Due to Material Inclusions
Biomet U.K., Ltd. is recalling Oxford Unicompartmental Knee Phase 3 Shim Size 3 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 a structural defect (cracking and separation) in a surgical instrument, which poses a risk of harm during use, but no specific injuries or illnesses are reported in the source text.
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 the Oxford Unicompartmental Knee Phase 3 Shim Size 3, which are instruments used with the Oxford Uni Partial Knee System. A total of 72 units are involved in this recall.
The recall is being conducted due to potential alumina inclusions in the raw material batch used to produce the affected products. These inclusions contained within the finished product could lead to the cracking and separation of the instrument.
The affected lots are ZB160601 and ZB160701, with item number 32-420665. The products 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 Unicompartmental Knee Phase 3 Shim Size 3 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:32-420665
- 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
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
FDA (Devices) · 2017-03-01
- 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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