BEUDAMED
    FDA Recall Terminated

    OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.

    Recall: Z-0169-2020 · Initiated September 11, 2019

    Recall

    Recall Number
    Z-0169-2020
    Event Number
    83844
    Firm
    OMNIlife science Inc.
    FEI Number
    3008342029
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 11, 2019
    Terminated
    April 27, 2020
    Address
    480 Paramount Dr, Raynham, MA, 02767-1085

    Description

    OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.

    Reason

    Stems missing porous coating on the device.

    Action

    1. Identify the affected product in your inventory 2.Immediately hold or quarantine the Lot # 33035 3. Return Product to OMNI at 480 Paramount Drive, Raynham MA 02767 3. Fill out the acknowledgement form and return the Form by FAX to 508-819-3390 or my email to [email protected] For further information contact Christina Rovaldi, Regulatory Affairs 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

    OK, IL

    Quantity

    3 units