Biomet Oxford Partial Knee Instruments Recalled for 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 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 risk-of-harm product (medical instrument failure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Biomet U.K., Ltd. is conducting a medical device field action for specific lots of Oxford Partial Knee System instruments. The affected products are the Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D, with a total of 72 units involved. The specific item number is 32-420060 and the lot number is ZB160701.
The recall is being conducted because of potential alumina inclusions in the raw material batch used to produce these instruments. These inclusions could lead to the cracking and separation of the instrument during use.
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 that have received these instruments should stop using them and contact Biomet U.K., Ltd. for further instructions.
The recalled product
- Product
- Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D 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:32-420060
- Lots: 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
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See all →- HighBiomet Oxford Knee Instruments Recalled for Potential Material Inclusions
FDA (Devices) · 2017-03-01
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- HighBiomet Recalls Oxford Knee Instruments Due to Material Inclusions
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- HighBiomet Oxford Knee Instruments Recalled for Material Inclusions
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- HighBiomet Recalls Oxford Partial Knee Instruments Due to Material Inclusions
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