BEUDAMED
    FDA Enforcement Class II Ongoing

    RipCord Syndesmosis Button, REF: STA001K

    Recall: Z-1101-2023 · Reported February 15, 2023

    Enforcement

    Recall Number
    Z-1101-2023
    Event ID
    91478
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TriMed Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 15, 2023
    Initiation Date
    December 22, 2022
    Classification Date
    February 7, 2023
    Address
    27533 Avenue Hopkins, Santa Clarita, CA, 91355-3910, United States

    Description

    RipCord Syndesmosis Button, REF: STA001K

    Reason

    Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.

    Code Info

    UDI-DI: 00842188123849, Lot: 85305-01

    Distribution

    US Nationwide distribution in the states of IL, PA, TX, GA, TN, AL, MO, FL, AR, LA, HI, OH, TX, KS

    Quantity

    76