BEUDAMED
    FDA Enforcement Class II Terminated

    Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.

    Recall: Z-2877-2018 · Reported August 29, 2018

    Enforcement

    Recall Number
    Z-2877-2018
    Event ID
    80487
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TriMed Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 29, 2018
    Initiation Date
    April 16, 2018
    Classification Date
    August 18, 2018
    Termination Date
    January 28, 2021
    Address
    27533 Avenue Hopkins, Santa Clarita, CA, 91355-3910, United States

    Description

    Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for use in osteotomy procedures of the ulna.

    Reason

    Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate

    Code Info

    Lot Numbers: 10003, 10017

    Distribution

    Worldwide Distribution in the state of TX and countries of Australia, China Sweden

    Quantity

    722