BEUDAMED
    FDA Enforcement Class II Ongoing

    G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty

    Recall: Z-0007-2023 · Reported October 12, 2022

    Enforcement

    Recall Number
    Z-0007-2023
    Event ID
    90858
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 12, 2022
    Initiation Date
    August 25, 2022
    Classification Date
    October 5, 2022
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty

    Reason

    The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.

    Code Info

    Item No. 010000663 UDI-DI: 00880304524224 Lots: 7286477 7289929 7296576 7296633 7301697 Exp. 21-Jul-32 Item No. 010000667 UDI-DI: 00880304524262 Lot: 7253325 Exp. 13-Jun-32

    Distribution

    Domestic distribution US nationwide.

    Quantity

    56 US