FDA-Device2018-02-28Class II
Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
Zimmer Biomet, Inc.
Hazard
Knee implant components (tibial bearings) are labeled with the incorrect size.
Sold states
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
Affected count
24
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0673-2018Don't want to check this manually?
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