BEUDAMED
    FDA Enforcement Class II Terminated

    INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

    Recall: Z-1594-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1594-2013
    Event ID
    65297
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    May 28, 2013
    Classification Date
    June 25, 2013
    Termination Date
    May 13, 2014
    Address
    1800 Pyramid Place, Memphis, TN, 38132, United States

    Description

    INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic

    Reason

    Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.

    Code Info

    Lots: M111063AAF, M111064AAN

    Distribution

    Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.

    Quantity

    400 units