BEUDAMED
    FDA Recall Terminated

    Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute

    Recall: Z-1746-2011 · Initiated January 30, 2011

    Recall

    Recall Number
    Z-1746-2011
    Event Number
    57824
    Firm
    Organogenesis, Inc.
    FEI Number
    1000148471
    Product Code
    MGR
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    January 30, 2011
    Posted
    March 23, 2011
    Terminated
    July 28, 2011
    Address
    150 Dan Road, Canton, MA, 02021-2820

    Description

    Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute

    Reason

    Product sterility compromised

    Action

    Organogenesis notified accounts on Sunday, January 30, 2011, via fax and phone. The Company will collect written confirmation from the affected customers that they have been notified of the recall. Sales representatives for the affected customers have been directed to visit the customers as soon as possible Monday morning to assist in the recall and prevent additional applications of the product. Apligraf Medical Affairs personnel will provide clinical support to treating physicians, and update them as new information on microbial contamination and antibiotic susceptibility becomes available. Units not applied have been requested to be returned to Organogenesis

    Distribution

    nationwide.

    Quantity

    50 units