BEUDAMED
    FDA Enforcement Class II Terminated

    G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.

    Recall: Z-0626-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0626-2018
    Event ID
    79104
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    August 25, 2017
    Classification Date
    February 15, 2018
    Termination Date
    August 16, 2018
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint.

    Reason

    The affected products are labeled and etched as F-44 mm liners; however, the physical products could potentially be E-42 mm liners.

    Code Info

    Item #110024464 Lot# 478340

    Distribution

    US Nationwide Distribution

    Quantity

    8