BEUDAMED
    FDA Recall Terminated

    Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591

    Recall: Z-2500-2020 · Initiated May 12, 2020

    Recall

    Recall Number
    Z-2500-2020
    Event Number
    85789
    Firm
    XTANT Medical
    FEI Number
    3005031160
    Product Code
    HWA
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 12, 2020
    Terminated
    March 19, 2021
    Address
    664 Cruiser Ln, Belgrade, MT, 59714-9719

    Description

    Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591

    Reason

    The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld.

    Action

    On May 12, 2020 a customer letter (in an envelope marked URGENT) was Federal Expressed priority overnight-signature required to the three customers who received the affected devices. On May 19, 2020, an additional customer letter (in an envelope marked URGENT) was Federal Expressed priority overnight-signature required to one of the three affected customers.

    Distribution

    AZ, TX and WV.

    Quantity

    4 units