BEUDAMED
    FDA Recall Terminated

    Apligraf (Graftskin)

    Recall: Z-0068-2007 · Initiated September 29, 2006

    Recall

    Recall Number
    Z-0068-2007
    Event Number
    36468
    Firm
    Organogenesis, Inc.
    FEI Number
    1000148471
    Product Code
    MGR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2006
    Posted
    October 24, 2006
    Terminated
    March 12, 2007
    Address
    150 Dan Road, Canton, MA, 02021-2820

    Description

    Apligraf (Graftskin)

    Reason

    Product pH out of specification

    Action

    Organogenesis notified customers by fax on 9/29/06 through 10/2/06. Follow-Up telephone calls are being made. Users are requested to examine units for pH and return if product is out of spec., or verify unit was in spec for pH at time of use.

    Distribution

    Nationwide

    Quantity

    58