BEUDAMED
    FDA Enforcement Class II Ongoing

    Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

    Recall: Z-1649-2022 · Reported September 7, 2022

    Enforcement

    Recall Number
    Z-1649-2022
    Event ID
    90670
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    New Standard Device Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 7, 2022
    Initiation Date
    December 28, 2020
    Classification Date
    August 29, 2022
    Address
    4848 Research Dr, San Antonio, TX, 78240-5005, United States

    Description

    Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080

    Reason

    Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.

    Code Info

    Part Number / DESCRIPTION / UDI-DI Code / Lot Numbers: 620030 / Self-Drill Half-Pin 5x30x215mm / 854641008198 / A29418X, A17219CA 620040 / Self-Drill Half-Pin 5x40x215mm / 854641008204 / A29418Y, A17219CB 620060 / Self-Drill Half-Pin 5x60x215mm / 854641008211 / A29418Z, A17219CC 620080 / Self-Drill Half-Pin 5x80x215mm / 854641008228 / A29518A, A17219CD

    Distribution

    U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None

    Quantity

    410 total devices