BEUDAMED
    FDA Enforcement Class II Ongoing

    TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only

    Recall: Z-1791-2024 · Reported May 22, 2024

    Enforcement

    Recall Number
    Z-1791-2024
    Event ID
    94381
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TriMed Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 22, 2024
    Initiation Date
    March 19, 2024
    Classification Date
    May 10, 2024
    Address
    27533 Avenue Hopkins, N/A, Santa Clarita, CA, 91355-3910, United States

    Description

    TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only

    Reason

    Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.

    Code Info

    UDI: 00842188127878/ Lot # QM23086

    Distribution

    US Nationwide distribution in the states of AK, AR, AZ, CA, FL, HI, IL, LA, MA, MI, NC, NJ, NV, OH, OK, PA, TN, TX, UT, VA, WA, WI.

    Quantity

    142 units