BEUDAMED
    FDA Enforcement Class II Terminated

    TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.

    Recall: Z-0118-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0118-2020
    Event ID
    83563
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TriMed Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2019
    Initiation Date
    August 24, 2018
    Classification Date
    October 10, 2019
    Termination Date
    April 28, 2021
    Address
    27533 Avenue Hopkins, N/A, Santa Clarita, CA, 91355-3910, United States

    Description

    TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.

    Reason

    Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.

    Code Info

    Lot numbers 28884, 28885, 28886, and 28887

    Distribution

    Distribution was made to CA, FL, MD, TX, and WA. There was military and foreign distribution was made to Australia. There was no government distribution.

    Quantity

    5 devices