BEUDAMED
    FDA Recall Terminated

    Stryker VertePort, 10 G Access Canula (short), REF 306-430, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.

    Recall: Z-1194-2008 · Initiated February 13, 2008

    Recall

    Recall Number
    Z-1194-2008
    Event Number
    46726
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    JDZ
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    February 13, 2008
    Posted
    March 11, 2008
    Terminated
    December 30, 2008
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    Stryker VertePort, 10 G Access Canula (short), REF 306-430, Qty 6; For use with the Stryker PCD Precision System and ACM Delivery System, Rx only, sterile, Stryker Instruments, Kalamazoo, MI.

    Reason

    Mis-labeling; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy)

    Action

    Consignees were notified via Medical Device Recall Notification letter dated 2/13/08 to read the enclosed instructions for use, remove all old instructions for use at the consignee location and replace them with the new instructions for use, and to discard the old instructions for use.

    Distribution

    Nationwide.

    Quantity

    953 boxes Recalls Z-1192-1195-2008