BEUDAMED
    FDA Recall Terminated

    St. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD) System, 14 mm X STOP implants in peel pouch, Catalog #1-2210; The X STOP consists of a main body, a spacer, and a tissue expander that is secured using a universal wing assembly consisting of a wing and a setscrew. Product is distributed by St. Francis Medical Technologies, Inc., 960 Atlantic Avenue, Suite 102, Alameda, CA 94501

    Recall: Z-1258-06 · Initiated June 6, 2006

    Recall

    Recall Number
    Z-1258-06
    Event Number
    35621
    Firm
    St. Francis Medical Technologies Inc
    FEI Number
    3004904811
    Product Code
    NQO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 6, 2006
    Posted
    July 26, 2006
    Terminated
    November 21, 2006
    Address
    960 Atlantic Ave, 102, Alameda, CA, 94501

    Description

    St. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD) System, 14 mm X STOP implants in peel pouch, Catalog #1-2210; The X STOP consists of a main body, a spacer, and a tissue expander that is secured using a universal wing assembly consisting of a wing and a setscrew. Product is distributed by St. Francis Medical Technologies, Inc., 960 Atlantic Avenue, Suite 102, Alameda, CA 94501

    Reason

    Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant.

    Action

    On May 22, 2006, the firm initiated the recall and notification via letters explaining the reason for the recall and requesting the product be returned.

    Distribution

    Worldwide

    Quantity

    4 units