BEUDAMED
    FDA Recall Completed

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

    Recall: Z-1401-2023 · Initiated March 8, 2023

    Recall

    Recall Number
    Z-1401-2023
    Event Number
    91947
    Firm
    Medacta Usa Inc
    FEI Number
    3006639916
    Product Code
    OVD
    Status
    Completed
    Root Cause
    Under Investigation by firm
    Initiated
    March 8, 2023
    Posted
    April 19, 2023
    Address
    3973 Delp St, Memphis, TN, 38118-6110

    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.

    Action

    Medacta USA initially notified its direct consignees by telephone on 03/08/2023 and followed with an URGENT - Field Safety Notice sent by email on 03/22/2023. The notice explained the issue and requested the units be returned and the notice be sent forward to all people and organizations potentially affected.

    Distribution

    US: ID, TX, GA, VA, AZ

    Quantity

    53 units