Biomet Recalls Oxford Partial Knee Instruments Due to Material Inclusions
Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall, and the source text indicates a risk of instrument cracking and separation, which aligns with the rubric criteria for Severe severity involving significant injury potential or structural defects.
Plain-English summary
Biomet U.K., Ltd. is conducting a medical device field action for specific lots of Oxford Partial Knee System instruments. The recall involves the Right Medial Tibial Trial Tray Size C, with a total of 72 units affected. The specific item number is 32-420733, and the affected lots are ZB160501 and ZB160601.
The action is being taken because of potential alumina inclusions in the raw material batch used to produce these products. These inclusions could lead to the cracking and separation of the instruments during use. The agency has classified this as a Class II recall.
The affected instruments 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 U.K., Ltd. for further instructions.
The recalled product
- Product
- Oxford Partial Knee System Right Medial Tibial Trial Tray Size C 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: 32-420733
- 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
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
Same hazard · structural failure
See all →- High
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- ModerateQuantum Ops Recalls ADAPTABLE Beach Chair Surgical Patient Positioners
FDA (Devices) · 2026-10-14
- SeverePacearth Recalls Swing Seats Due to Serious Injury Risk from Falling
CPSC · 2026-10-08
Similar recalls
- HighOxford Partial Knee System Recalled for Compromised Sterile Barrier
FDA (Devices) · 2023-02-01
- HighBiomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw
FDA (Devices) · 2013-07-17
- SevereBiomet Recalls Oxford Fixed Bearing Partial Knee Components
FDA (Devices) · 2013-07-17
- HighBiomet Oxford Partial Knee Systems Recalled for Elevated Endotoxin Levels
FDA (Devices) · 2020-06-03
- HighBiomet Oxford Uni Knee System Toffee Hammer Recalled for Weld Cracking
FDA (Devices) · 2013-04-24
- HighBiomet Recalls Oxford Fixed Bearing Partial Knee Implants
FDA (Devices) · 2013-07-17