Biomet Recalls Oxford Fixed Bearing Partial Knee Implants
Biomet is recalling 20 Oxford Fixed Bearing Partial Knee implants due to a design defect that may cause anterior impingement between bone and the poly bearing component.
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 design defect in a medical device that poses a risk of harm (impingement) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Biomet, Inc. is recalling 20 units of the REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia, Size C7. 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.
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. The affected units are sterile and made of ARCOM UHMWPE and CO-CR-MO Alloy.
The recalled products were distributed worldwide, including in the United States (North Carolina, Indiana, Pennsylvania, and Ohio), Canada, and the Netherlands. Affected lot codes include M584380, M754830, M969160, M444820, and M987510. Healthcare providers and patients should contact Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 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
- 20
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)
- M584380
- M754830
- M969160
- M444820
- M987510
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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