Device product
REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 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 tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Z-1722-2013
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 65459
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23
- Official record key
device-enforcement:Z-1722-2013
Official wording
Reason: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Code information: M561250, M657110, M017540, M166880, M920640, M886440
Distribution pattern: Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
Derived failure modes
-
Unknown
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.