Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total…

Recall date
September 29, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0673-2018
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands

Why it was recalled

Knee implant components (tibial bearings) are labeled with the incorrect size.

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 Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty

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