Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw
Biomet is recalling 37 Oxford Fixed Bearing Partial Knee components because a design flaw may cause bone to impinge on the bearing.
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 flaw in a medical device that poses a risk of harm (impingement) without reported injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 37 units of the Oxford Fixed Bearing Partial Knee, specifically the Cemented Lateral Tibia Size D4 (REF 154222). The affected devices are sterile, fixed bearing components intended for use in the lateral compartment of the knee 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 could lead to mechanical complications during knee movement.
The affected units were distributed worldwide, including in the United States (North Carolina, Indiana, Pennsylvania, and Ohio), Canada, and the Netherlands. Healthcare providers and patients who have received these specific components should contact Biomet for further instructions on removal or replacement.
The recalled product
- Product
- REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 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
- 37
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 (5)
- M598320
- M480940
- M987300
- M444840
- M656990
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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