BEUDAMED
    FDA Enforcement Class II Terminated

    TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization.

    Recall: Z-0366-2020 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0366-2020
    Event ID
    83984
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TriMed Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2019
    Initiation Date
    August 15, 2018
    Classification Date
    November 13, 2019
    Address
    27533 Avenue Hopkins, N/A, Santa Clarita, CA, 91355-3910, United States

    Description

    TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended to penetrate the small terminal fragment to provide additional stabilization.

    Reason

    The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.

    Code Info

    Lot # 110631,

    Distribution

    US Nationwide distribution in the states of MD, UT.

    Quantity

    583 Bone Plates