BEUDAMED
    FDA Recall Completed

    Bard Composix Kugel Hernia Patch- Large Circle 4.5'' with ePTFE Product Code: 0010204

    Recall: Z-0360-2007 · Initiated January 10, 2007

    Recall

    Recall Number
    Z-0360-2007
    Event Number
    36990
    Firm
    Davol, Inc., Sub. C. R. Bard, Inc.
    FEI Number
    1213643
    Product Code
    FTL
    Status
    Completed
    Root Cause
    Other
    Initiated
    January 10, 2007
    Posted
    January 30, 2007
    Address
    100 Sockanossett Crossroad, Cranston, RI, 02920

    Description

    Bard Composix Kugel Hernia Patch- Large Circle 4.5'' with ePTFE Product Code: 0010204

    Reason

    PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula

    Action

    Davol Inc. notified Hospital Administrators/Risk Health Managers,distributors, and surgeons of the expanded recall by letter beginning 1/10/07. Product under recall is to be returned to Davol for replacement. Davol is posting recall information to their website.

    Distribution

    Nationwide

    Quantity

    16,603 units