Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
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 is classified as FDA Class II. The hazard involves a design defect creating potential for impingement, which is a risk-of-harm product issue where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Biomet, Inc. is recalling 25 units of the REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia, Size F4. The product is a partial knee replacement system intended for use in the lateral compartment of the knee and is indicated for implementation with bone cement.
The recall was initiated after a Biomet investigation found that the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. The affected units are sterile and consist of ARCOM UHMWPE and CO-CR-MO Alloy materials.
The recalled products were distributed worldwide, including in the United States (specifically North Carolina, Indiana, Pennsylvania, and Ohio), Canada, and the Netherlands. Affected lot codes include M632980, M539460, M657100, M017530, M166870, M920620, and M886430. Healthcare providers should contact Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing…
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 25
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 (7)
- M632980
- M539460
- M657100
- M017530
- M166870
- M920620
- M886430
Distribution
Part of a larger recall action
This product is one of 30 recalled by Biomet, Inc. 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.
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