BEUDAMED
    FDA Enforcement Class II 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 · Reported November 24, 2021

    Enforcement

    Recall Number
    Z-0237-2022
    Event ID
    88890
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OmniLife Science
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 24, 2021
    Initiation Date
    October 1, 2021
    Classification Date
    November 16, 2021
    Termination Date
    July 20, 2022
    Address
    480 Paramount Dr, N/A, Raynham, MA, 02767-1085, United States

    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.

    Code Info

    UDI 00841690102496 Lot 38933

    Distribution

    US Distribution to states of: Colorado and Virginia.

    Quantity

    7