BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2110-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2110-2017
    Event ID
    77121
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Molnlycke Health Care, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    April 24, 2017
    Classification Date
    May 18, 2017
    Address
    5550 Peachtree Pkwy Ste 500, Norcross, GA, 30092-2555, United States

    Description

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

    Reason

    Sterilization validation failure.

    Code Info

    Code: 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504 and 131506.

    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