BEUDAMED
    FDA Recall 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 · Initiated August 24, 2018

    Recall

    Recall Number
    Z-0118-2020
    Event Number
    83563
    Firm
    TriMed Inc.
    FEI Number
    3001236812
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 24, 2018
    Posted
    October 10, 2019
    Terminated
    April 28, 2021
    Address
    27533 Avenue Hopkins, Santa Clarita, CA, 91355-3910

    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.

    Action

    The recalling firm issued letters via email on 8/24/2018 informing the distributor of the medical facility of the issue. The distributor is then responsible for notifying the medical facility to whom the device is invoiced.

    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