BEUDAMED
    FDA Enforcement Class II Completed

    MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device

    Recall: Z-1401-2023 · Reported April 26, 2023

    Enforcement

    Recall Number
    Z-1401-2023
    Event ID
    91947
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Medacta Usa Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 26, 2023
    Initiation Date
    March 8, 2023
    Classification Date
    April 19, 2023
    Address
    3973 Delp St, N/A, Memphis, TN, 38118-6110, United States

    Description

    MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device

    Reason

    There is a potential for breakage of the small screw used to affix the anti-backout plate.

    Code Info

    UDI/DI 07630345732293, All Lot Numbers

    Distribution

    US: ID, TX, GA, VA, AZ

    Quantity

    53 units