Biomet Recalls Oxford Knee Instruments Due to Material Inclusions
Biomet U.K., Ltd. is recalling Oxford Knee System Tibial Resector Body Tubes and Guides 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 risk-of-harm product (medical instrument failure) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness or injury.
Plain-English summary
Biomet U.K., Ltd. is conducting a medical device field action for specific lots of Oxford Knee System Tibial Resector Body Tubes and Guides. The recall involves 72 units in total, identified by item number 32-423200 and lot numbers ZB160602, ZB160701, and ZB160801.
The action is being taken because the raw material batch used to produce these instruments may contain alumina inclusions. If present in the finished product, these inclusions could lead to the cracking and separation of the instrument during use.
The affected products were distributed worldwide, including in the U.S. states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, and OK, as well as in Thailand, Japan, and the Netherlands. These instruments are intended for use with the Oxford Uni Partial Knee System.
The recalled product
- Product
- Oxford Knee System Tibial Resector Body Tube & Guides 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: 32-423200
- Lots: ZB160602 ZB160701
- ZB160801
- OXF TIB RESECT BODY TUBE & GD
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 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 Oxford Knee Instruments Recalled for Material Inclusions
FDA (Devices) · 2017-03-01
- HighBiomet Recalls Oxford Partial Knee Instruments Due to Material Inclusions
FDA (Devices) · 2017-03-01
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