Device product
Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. 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. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Z-2065-2015
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 71529
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18
- Official record key
device-enforcement:Z-2065-2015
Official wording
Reason: Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link.
Code information: Part Number: 32-423400 Lot Numbers: 238220, 664720,489620, 490930,021410, 507150
Distribution pattern: Worldwide Distribution - US Nationwide in the states of NC, IN, PA, OH and the country of the Netherlands.
Derived failure modes
-
Unknown
Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link.