BEUDAMED
    FDA Enforcement Class II Terminated

    Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.

    Recall: Z-0656-2013 · Reported January 16, 2013

    Enforcement

    Recall Number
    Z-0656-2013
    Event ID
    61718
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 16, 2013
    Initiation Date
    October 23, 2012
    Classification Date
    January 8, 2013
    Termination Date
    September 11, 2013
    Address
    325 Corporate Drive, Mahwah, NJ, 07430, United States

    Description

    Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.

    Reason

    Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix.

    Code Info

    Catalog Number: 6021-2530 Lot #40264005 Catalog Number: 6021-3535 Lot #40163005. This lot was not received in the US.

    Distribution

    Nationwide distribution, including the states of NY, NJ, CA and FL.

    Quantity

    6021-2530- four units; 6021-3535-