BEUDAMED
    FDA Recall 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 · Initiated August 15, 2018

    Recall

    Recall Number
    Z-0366-2020
    Event Number
    83984
    Firm
    TriMed Inc.
    FEI Number
    3001236812
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 15, 2018
    Address
    27533 Avenue Hopkins, Santa Clarita, CA, 91355-3910

    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.

    Action

    On 08/15/2019 and 9/13/19, the firm issued a recall notice to affected consignees via email. The recall notification informed consignees of the following: 1. Review your inventory to see if you have any of the impacted product. If you have impacted product within your inventory, remove the product use. Do not implant the impacted product. Contact TriMed at [email protected] or call 800-633-7221. TriMed will arrange to have the impacted product returned to the company. 2. Review your records to see if the impacted product was implanted. If you have records that impacted product was implanted, medical judgment should be applied to determine whether additional patient monitoring activities should be performed to evaluate implant placement, implant structural integrity, and fracture union. 3. Return the Recall Response card attached to this letter to TriMed as soon as possible. 4. Please contact TriMed via telephone or email as per below if you have any questions:, Telephone*: 800-633-7221 Email: [email protected], Hours of operation: 8:00AM to 5:00PM PST (Monday through Friday, excluding holidays)

    Distribution

    US Nationwide distribution in the states of MD, UT.

    Quantity

    583 Bone Plates