BEUDAMED
    FDA Enforcement Class II 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 · Reported October 30, 2019

    Enforcement

    Recall Number
    Z-0169-2020
    Event ID
    83844
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OMNIlife science Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2019
    Initiation Date
    September 11, 2019
    Classification Date
    October 21, 2019
    Termination Date
    April 27, 2020
    Address
    480 Paramount Dr, Raynham, MA, 02767-1085, United States

    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.

    Code Info

    Lot # 33035

    Distribution

    OK, IL

    Quantity

    3 units