BEUDAMED
    FDA Enforcement Class II Ongoing

    G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462

    Recall: Z-1284-2023 · Reported March 29, 2023

    Enforcement

    Recall Number
    Z-1284-2023
    Event ID
    91866
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2023
    Initiation Date
    February 6, 2023
    Classification Date
    March 23, 2023
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462

    Reason

    The outer package labeling and product etch are a 40 mm Size D liner, however, the implant is a 38 mm Size C liner.

    Code Info

    UDI: (01)00880304703506(17)321128(10)65731960; Lot Number: 65731960

    Distribution

    US Distribution to states of: AZ, FL, GA, MI, NE, and TX.

    Quantity

    12 units