BEUDAMED
    FDA Recall Terminated

    Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080

    Recall: Z-0401-05 · Initiated December 27, 2004

    Recall

    Recall Number
    Z-0401-05
    Event Number
    30759
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 27, 2004
    Posted
    January 15, 2005
    Terminated
    March 18, 2005
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080

    Reason

    The label on the outside of the shipping box has an incorrect description of the screw diameter.

    Action

    Consignees have been alerted by phone calls on 12/16/2004. Formal advisory notice was sent out on 12/27/2004. All international consignees have also been alerted.

    Distribution

    6 consignees (locations to be determined) received 15 units. the remaining 147 units were distributed to international divisions.

    Quantity

    16 units of 078, 284 units of 080