Biomet Recalls Oxford Partial Knee Trial Trays Due to Material Inclusions
Biomet U.K., Ltd. is recalling Oxford Partial Knee System trial trays 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 recall is classified as FDA Class II and involves a structural defect (cracking and separation) in a surgical instrument, which aligns with the rubric criteria for a Severe rating.
Plain-English summary
Biomet U.K., Ltd. is conducting a medical device field action for specific lots of the Oxford Partial Knee System Right and Left Medial Tibial Trial Tray Size C. The recall involves 72 units in total, identified by item number 32-420732 and lot numbers ZB160501, ZB160601, and ZB160801.
The action is being taken because the raw material batch used to produce these instruments may contain alumina inclusions. These inclusions could lead to the cracking and separation of the finished product. The FDA has classified this as a Class II recall.
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 Right Medial Tibial Trial Tray Size C Oxford Partial Knee System Left Medial Tibial Trial Tray Size C
- 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 (4)
- Item:32-420732
- Lots: ZB160501
- ZB160601
- ZB160801
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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