FDA-Device2018-03-21Class II

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

Zimmer Biomet, Inc.
Hazard

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

Sold states
US Distribution to states of: FL, WI, MD, MO, and MI.
Affected count
8
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1011-2018

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