Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components due to a design flaw 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), fitting the criteria for a High severity score.
Plain-English summary
Biomet, Inc. is recalling 26 units of the Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia, Size D7. The affected components are sterile and 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 affect the function of the knee implant.
The recalled products were distributed worldwide, including in the United States (North Carolina, Indiana, Pennsylvania, and Ohio), Canada, and the Netherlands. Patients who have had this specific implant should contact their orthopedic surgeon to discuss the findings and determine if any further action is necessary.
The recalled product
- Product
- REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 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 t
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 26
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)
- M619800
- M106200
- M444870
- M657020
- M987640
- M987330
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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