Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 31 units of Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
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 hazard involves a structural design defect in a medical device that poses a risk of harm (impingement) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Biomet, Inc. is recalling 31 units of the Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia, Size E7. The affected 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. This design issue poses a risk of mechanical interference during knee movement.
The affected units were distributed worldwide, including in the United States (specifically North Carolina, Indiana, Pennsylvania, and Ohio), Canada, and the Netherlands. Healthcare providers and patients who have received this specific implant should contact Biomet for further instructions regarding the recall.
The recalled product
- Product
- REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 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
- 31
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 (6)
- M921180
- M539440
- M444920
- M722450
- M136990
- M657080
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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