Biomet Oxford Knee Instruments Recalled for Potential Material Inclusions
Biomet U.K., Ltd. is recalling Oxford Partial Knee System Femoral Slap Hammers due to potential alumina inclusions that could cause the instruments to crack or separate.
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 3/5 (High).
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 medical device with a risk of cracking and separation during surgical use, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Biomet U.K., Ltd. is conducting a medical device field action for specific lots of the Oxford Partial Knee System Femoral Slap Hammer. The recall involves 72 units of these surgical instruments, which are used with the Oxford Uni Partial Knee System.
The action is being taken because the raw material batch used to produce the affected products may contain alumina inclusions. These inclusions could lead to the cracking and separation of the finished instrument 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, OK, SC, and NJ, as well as in Thailand, Japan, and the Netherlands. The specific item number is 32-422365. Healthcare providers and facilities should stop using the affected instruments and contact Biomet for further instructions.
The recalled product
- Product
- Oxford Partial Knee System Femoral Slap Hammer 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: 32-422365
- Lots:
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 Oxford Partial Knee Instruments Recalled for Material Inclusions
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- HighBiomet Recalls Oxford Knee Instruments Due to Material Inclusions
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