Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 28 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone 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 involves a medical device with a design defect that creates a potential for physical impingement, representing a risk of harm where specific injury reports are not detailed in the source text.
Plain-English summary
Biomet, Inc. is recalling 28 units of the Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia (REF 154231). These medical devices are partial knee replacement systems intended for use in the lateral compartment of the knee and are distributed worldwide, including in the United States, Canada, and the Netherlands.
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 design issue may affect the function of the knee implant.
Healthcare providers and patients who have received these specific components should contact Biomet, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 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
- 28
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)
- M321600
- M539430
- M444910
- M657070
- M722440
- M136980
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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