Recall Z-2065-2015— Biomet, Inc.

Class II FDA medical device recall by Biomet, Inc., initiated 2015-06-03, terminated 2016-03-15. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..

Recalling firm

Biomet, Inc.

Classification

Class II

Status

Terminated

Initiated

2015-06-03

Terminated

2016-03-15

Firm location

Warsaw, IN, United States

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