BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254

    Recall: Z-0811-2020 · Reported January 22, 2020

    Enforcement

    Recall Number
    Z-0811-2020
    Event ID
    84346
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2020
    Initiation Date
    November 7, 2019
    Classification Date
    January 15, 2020
    Termination Date
    August 31, 2020
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006, United States

    Description

    Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254

    Reason

    May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire

    Code Info

    Lot Number: 53778501 UDIs: (01)04546540035806(17)201108(10)53778501

    Distribution

    CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan

    Quantity

    20 units