BEUDAMED
    FDA Recall Terminated

    Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile; Arc Deposited, V40 taper Not for use with 16mm heads.

    Recall: Z-0557-2010 · Initiated January 14, 2009

    Recall

    Recall Number
    Z-0557-2010
    Event Number
    51180
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 14, 2009
    Posted
    December 22, 2009
    Terminated
    July 18, 2012
    Address
    325 Corporate Dr, Mahwah, NJ, 07430

    Description

    Stryker Howmedica Osteonics, Primary Super SecurFit Stems, hip prosthesis, Sterile; Arc Deposited, V40 taper Not for use with 16mm heads.

    Reason

    Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.

    Action

    Stryker sent Urgent product Correction Letters on January 14, 2009 by Federal Express to Stryker branches/agencies, hospital risk management, chief of orthopaedics and surgeon.

    Distribution

    Nationwide. Product was distributed to 3 Stryker branches/agencies and 2 hospitals in PA and CA.

    Quantity

    786 total stems