Biomet Recalls Oxford Knee Instruments Due to Material Inclusions
Biomet U.K. is recalling Oxford Partial Knee 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 classification is Class II, and the source describes a structural defect (cracking and separation) which poses a significant risk of injury during use, meeting the criteria for a Severe rating.
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 72 units of the Left Medial Tibial Trial Tray Size B, identified by item number 32-420730 and lots 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 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. for instructions on return or replacement. This is a Class II recall, indicating that use of or exposure to the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Oxford Partial Knee System Left Medial Tibial Trial Tray 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 (4)
- Item:32-420730
- 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
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See all →- HighBiomet Oxford Knee Instruments Recalled for Material Inclusions
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- HighBiomet Recalls Oxford Knee Instruments Due to Material Inclusions
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- 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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