Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw
Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components because a design flaw creates a potential for anterior impingement between bone and the poly 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 involves a medical device with a design defect that creates a potential for injury (anterior impingement), but the source text does not report any actual illnesses, injuries, or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 22 units of the REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM. These medical devices are partial knee replacement systems consisting of a femoral component and a fixed bearing tibial component 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 poses a risk of harm to patients who have received these specific implants.
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 should contact Biomet, Inc. for further instructions regarding the removal or replacement of these devices.
The recalled product
- Product
- REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM 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 ti
- Manufacturer
- Biomet, Inc.
- Affected units
- 22
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 (4)
- M375490
- M444720
- M886400
- M956080
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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