BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated December 28, 2020

    Recall

    Recall Number
    Z-1649-2022
    Event Number
    90670
    Firm
    New Standard Device Inc
    FEI Number
    3015536247
    Product Code
    KTT
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    December 28, 2020
    Address
    4848 Research Dr, San Antonio, TX, 78240-5005

    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.

    Action

    On 12/28/2020, Metalogix send a "Field Notice: Self-Drill Half-Pin" via email. The Notice only informed customer that the Citieffe Half-Pins will temporarily be used to replace the current 5mm Self-Drill Half-Pins. A contact number for Mr. Elton Ely, QA Manager was provided in the notice 833-659-2019 ext. 6

    Distribution

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

    Quantity

    410 total devices