BEUDAMED
    FDA Recall Terminated

    Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in..

    Recall: Z-0904-03 · Initiated May 2, 2003

    Recall

    Recall Number
    Z-0904-03
    Event Number
    26327
    Firm
    Smith and Nephew Wound Management (La Jolla)
    FEI Number
    1000148471
    Product Code
    MGR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 2, 2003
    Posted
    June 4, 2003
    Terminated
    November 3, 2003
    Address
    10933 N Torrey Pines Road, Ste 200, San Diego, CA, 92037

    Description

    Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in..

    Reason

    Did not meet finished device specifications for the DNA criteria.

    Action

    Recall was by telephone on or about May 2, 2003 and by letter on May 7, 2003. Product is to be returned.

    Distribution

    To hospitals nationwide.

    Quantity

    22