BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2500-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2500-2020
    Event ID
    85789
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    XTANT Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2020
    Initiation Date
    May 12, 2020
    Classification Date
    July 4, 2020
    Termination Date
    March 19, 2021
    Address
    664 Cruiser Ln, Belgrade, MT, 59714-9719, United States

    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.

    Code Info

    LOT: XS1920458A

    Distribution

    AZ, TX and WV.

    Quantity

    4 units