BEUDAMED
    FDA Enforcement Class II Terminated

    TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.

    Recall: Z-2051-2015 · Reported July 15, 2015

    Enforcement

    Recall Number
    Z-2051-2015
    Event ID
    71440
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2015
    Initiation Date
    June 3, 2015
    Classification Date
    July 8, 2015
    Termination Date
    September 15, 2015
    Address
    1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States

    Description

    TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.

    Reason

    A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.

    Code Info

    Part # 04.004.000, lot # 7950994

    Distribution

    US Distribution to states of: MO and SC.

    Quantity

    3