BEUDAMED
    FDA Recall Terminated

    XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #: 1161928

    Recall: Z-1381-2011 · Initiated January 7, 2011

    Recall

    Recall Number
    Z-1381-2011
    Event Number
    57566
    Firm
    Davol, Inc., Sub. C. R. Bard, Inc.
    FEI Number
    1213643
    Product Code
    FTM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 7, 2011
    Posted
    March 2, 2011
    Terminated
    October 31, 2013
    Address
    100 Crossings Blvd, Warwick, RI, 02886-2850

    Description

    XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix 19 x 28 cm Rectangle Catalog #: 1161928

    Reason

    Davol cannot guarantee that all Xenomatic product released from July to October 2010 meets FDA guidelines for endotoxin limits; and therefore, the grafts are potentially contaminated with bacteria.

    Action

    Davol issued recall notification to accounts by letter dated 1/06/11 requesting recalled units be returned. contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product to Davol. A fax sheet attached to the letter to be completed and fax to 1-401-825-8753.

    Distribution

    Nationwide

    Quantity

    1393 units