BEUDAMED
    FDA Recall Terminated

    AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

    Recall: Z-1763-2013 · Initiated June 17, 2013

    Recall

    Recall Number
    Z-1763-2013
    Event Number
    65553
    Firm
    LeMaitre Vascular, Inc.
    FEI Number
    1220948
    Product Code
    MAL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 17, 2013
    Posted
    July 22, 2013
    Terminated
    August 15, 2016
    Address
    63 2nd Ave, Burlington, MA, 01803-4413

    Description

    AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

    Reason

    Blood blushing/leaking from the surface of the graft after implantation

    Action

    LeMaitre Vascular, Inc.sent an Urgent Field Safety Notice daed June 19, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and return the affected device to MeMaitre Vascular which they will replace with a new unit. Customers with questions were instructed to call 781-221-2266, ext. 183. For questions regarding this recall call 781-425-1670, ext 108.

    Distribution

    Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.

    Quantity

    2 untis