BEUDAMED
    FDA Recall Terminated

    Precision Tack Transvaginal Sling Kit with Non-Absorbable, Polybustester Monofilament Suture (contains 1 Product Code 820-175) Product Code: 820-124

    Recall: Z-0263-06 · Initiated October 25, 2005

    Recall

    Recall Number
    Z-0263-06
    Event Number
    33993
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    GAD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 25, 2005
    Posted
    December 1, 2005
    Terminated
    June 20, 2007
    Address
    1 Boston Scientific Pl, Natick, MA, 01760-1536

    Description

    Precision Tack Transvaginal Sling Kit with Non-Absorbable, Polybustester Monofilament Suture (contains 1 Product Code 820-175) Product Code: 820-124

    Reason

    Sterility of device compromised due to breach in packaging

    Action

    Boston Scientific initiated the recall on October 25, 2005 to accouunts requesting the return of the product and completion of the Reply Verification Tracking Form.

    Distribution

    Nationwide

    Quantity

    15