Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw
Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components because a design flaw may cause bone impingement during full knee extension.
What this means for you
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, and the source describes a design flaw creating a potential for mechanical impingement (risk of harm) without reporting specific injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 22 units of the REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7. These medical devices are partial knee replacement systems intended for use in the lateral compartment of the knee. The specific units involved are sterile and utilize ARCOM UHMWPE and Co-Cr-Mo Alloy materials.
The recall was initiated after a Biomet investigation determined that the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. This mechanical issue could occur when the knee is fully straightened.
The affected units were distributed worldwide, including in the United States (North Carolina, Indiana, Pennsylvania, and Ohio), Canada, and the Netherlands. The specific lot codes associated with this recall are M375500, M886410, M444760, and M956090. Healthcare providers and patients should contact Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 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.
- Affected units
- 22
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)
- M375500
- M886410
- M444760
- M956090
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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Same hazard · mechanical impingement
See all →- HighBiomet Recalls Oxford Fixed Bearing Partial Knee Components
FDA (Devices) · 2013-07-17
- HighBiomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw
FDA (Devices) · 2013-07-17