BEUDAMED
    FDA Recall Open, Classified

    Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'

    Recall: Z-2110-2017 · Initiated April 24, 2017

    Recall

    Recall Number
    Z-2110-2017
    Event Number
    77121
    Firm
    Molnlycke Health Care, Inc
    FEI Number
    1629080
    Product Code
    FZW
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    April 24, 2017
    Posted
    May 3, 2017
    Address
    5550 Peachtree Pkwy, Ste 500, Norcross, GA, 30092-2555

    Description

    Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'

    Reason

    Sterilization validation failure.

    Action

    Consignees were notified by Urgent Safety Notice letter via certified mail on/about 4/24/2017.

    Distribution

    Domestic: U.S. Nationwide; Foreign: Austria, Australia, Bangladesh, Canada, Chile, Germany, Denmark, Finland, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Jordan, Korea, Kuwait, Malaysia, Norway, New Zealand, Peru, Saudi Arabia, Sweden Switzerland, Taiwan, Turkey, South Africa, United Arab Emirates.

    Quantity

    956 units