BEUDAMED
    FDA Recall Terminated

    Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS Z.I. Marticot - 33610 Cestas France.,Distributed by Howmedica Osteonics Corp. 325 Corporate Drive, Mahway, NJ 07430

    Recall: Z-1239-2007 · Initiated July 10, 2007

    Recall

    Recall Number
    Z-1239-2007
    Event Number
    38406
    Firm
    Stryker Spine
    FEI Number
    3004024955
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 10, 2007
    Posted
    September 21, 2007
    Terminated
    December 11, 2007
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS Z.I. Marticot - 33610 Cestas France.,Distributed by Howmedica Osteonics Corp. 325 Corporate Drive, Mahway, NJ 07430

    Reason

    Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod

    Action

    Product recall letters were sent to branches/agencies and hospitals on 7/10/2007 requesting product return.

    Distribution

    Worldwide- USA: Distributed to Stryker Branches/Agencies in MA, NY, NC. IN, MI, OK, TX,CO, AZ, WI, KS, CA, OR and hospitals in NC IN, MI, MO. KS, TZ, AZ, CA. OR and WA and Country of Italy

    Quantity

    1,300 in US, 123 in Italy