Biomet, Inc. recalls Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed Bearing Knee is a Partial kn…

Recall date

June 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2065-2015

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of NC, IN, PA, OH and the country of the Netherlands.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.