Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 25 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 injury (impingement), but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling 25 units of the REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4. These medical devices are partial knee replacement systems intended for use in the lateral compartment of the knee and are implemented 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 may affect the function of the knee implant.
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 should contact Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 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
- 25
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)
- M561240
- M632960
- M136950 M657040
- M722420
- M444890
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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