BEUDAMED
    FDA Recall Terminated

    Zimmer Dermacarriers II skin graft carriers, 6 to 1 dermacarrier, Rx, latex free, sterile, Qty 1, Zimmer, Dover, Ohio; REF 00-2195-014-00. Single use device for use during skin grafting procedures.

    Recall: Z-1552-2008 · Initiated April 3, 2008

    Recall

    Recall Number
    Z-1552-2008
    Event Number
    47334
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    FZW
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 3, 2008
    Posted
    July 30, 2008
    Terminated
    December 17, 2009
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Dermacarriers II skin graft carriers, 6 to 1 dermacarrier, Rx, latex free, sterile, Qty 1, Zimmer, Dover, Ohio; REF 00-2195-014-00. Single use device for use during skin grafting procedures.

    Reason

    Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.

    Action

    Consignees were notified via letter (Urgent: Medical Device Correction) dated 4/3/08 to identify their stocks on hand, verify package sealing, to discard any non-sealed packages, mail the Business Reply Card regardless if there are any remaining affected products.

    Distribution

    Worldwide Distribution --- including USA and countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, Ecuador, England, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iraq, Israel, Italy, Japan, Jordan, Kenya, Largos, Lebanon, Lithuania, Malta, Mexico, Morocco, Netherlands, Nigeria, Panama, Peru, Poland, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunis, Turkey and Venezuela.

    Quantity

    99345 of all units