Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty

Recall date
October 3, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1011-2018
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
US Distribution to states of: FL, WI, MD, MO, and MI.

Why it was recalled

The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.

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

What was recalled

Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty

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