Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design defect 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 involves a risk-of-harm product (medical device) where the hazard is potential impingement, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biomet, Inc. is recalling 25 units of the REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6. 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 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. The agency has classified this as a Class II recall.
The affected units were distributed worldwide, including in the United States (North Carolina, Indiana, Pennsylvania, and Ohio), Canada, and the Netherlands. The specific lot codes associated with this recall are M480960, M657120, M886450, M166890, and M920650. Healthcare providers and patients should contact Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 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)
- M480960
- M657120
- M886450
- M166890
- M920650
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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Same hazard · impingement
See all →- HighBiomet Recalls Oxford Fixed Bearing Partial Knee Components
FDA (Devices) · 2013-07-17
- HighBiomet Recalls Oxford Fixed Bearing Partial Knee Components
FDA (Devices) · 2013-07-17
- HighBiomet Recalls Oxford Fixed Bearing Partial Knee Components
FDA (Devices) · 2013-07-17
- HighBiomet Recalls Oxford Fixed Bearing Partial Knee Components
FDA (Devices) · 2013-07-17
- HighBiomet Recalls Oxford Fixed Bearing Partial Knee Components
FDA (Devices) · 2013-07-17