Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 32 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 source text describes a design defect creating a potential for injury (impingement) without explicitly reporting that injuries have already occurred, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 32 units of the Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia, Size C3. These medical devices are intended for use in the lateral compartment of the knee and are distributed worldwide, including in the United States (North Carolina, Indiana, Pennsylvania, and Ohio), Canada, and the Netherlands.
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 harm to patients who have received these specific implants.
Healthcare providers and patients who have received these specific components should contact Biomet, Inc. for further instructions on how to proceed. The affected units are identified by the following lot codes: M321570, M894590, M619770, M480930, M656950, M444780, and M969100.
The recalled product
- Product
- REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3 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
- 32
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)
- M321570
- M894590
- M619770
- M480930
- M656950 M444780
- M969100
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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