BEUDAMED
    FDA Recall Terminated

    OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.

    Recall: Z-0237-2022 · Initiated October 1, 2021

    Recall

    Recall Number
    Z-0237-2022
    Event Number
    88890
    Firm
    OmniLife Science
    FEI Number
    3008342029
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 1, 2021
    Terminated
    July 20, 2022
    Address
    480 Paramount Dr, Raynham, MA, 02767-1085

    Description

    OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.

    Reason

    The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.

    Action

    Affected agents and representatives were notified by email, with initial communication sent via a quarantine form on 10/1/21. Additional notices titled "Urgent Medical Device Recall" were emailed out on October 15, 2021. Customers were instructed to immediately quarantine lot 38933 and return the product to OMNI. Customers were provided with a response form and asked to complete and return the form to the recalling company by FAX to 508-819-3390 or my email at [email protected]. For further information contact Christina Rovaldi, RA/QA Manager at 774-226-1847 or 800-448-6664. Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.

    Distribution

    US Distribution to states of: Colorado and Virginia.

    Quantity

    7