BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0673-2018 · Reported February 28, 2018

    Enforcement

    Recall Number
    Z-0673-2018
    Event ID
    79161
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 28, 2018
    Initiation Date
    September 29, 2017
    Classification Date
    February 21, 2018
    Termination Date
    April 17, 2019
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

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

    Reason

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

    Code Info

    Lot Number: 388680, Exp. Date 5/19/2022

    Distribution

    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

    Quantity

    24