BEUDAMED
    FDA Enforcement Class II Terminated

    fastener, fixation, nondegradable, soft tissue

    Recall: Z-1009-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-1009-2018
    Event ID
    79273
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    October 25, 2017
    Classification Date
    March 14, 2018
    Termination Date
    May 12, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    fastener, fixation, nondegradable, soft tissue

    Reason

    It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.

    Code Info

    Item # 110019010 Lot #'s 017350 141990 142000 142020 167190 240720 240740 240770 257970 398710 398730 398740 398750 421780 421790 421800 465910 504120 813190 940370

    Distribution

    TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT

    Quantity

    429 units