BEUDAMED
    FDA Enforcement Class II Terminated

    Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400

    Recall: Z-1823-2015 · Reported July 1, 2015

    Enforcement

    Recall Number
    Z-1823-2015
    Event ID
    71357
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    X Spine Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 1, 2015
    Initiation Date
    April 7, 2015
    Classification Date
    June 22, 2015
    Termination Date
    October 1, 2015
    Address
    452 Alexandersville Rd, Miamisburg, OH, 45342-3658, United States

    Description

    Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400

    Reason

    The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.

    Code Info

    Model #: N60001068; Lot #: 2943-01; Serial #s: 46118, 46581, 47296, 47588, 47653, 48164, 48201, 48412, 49156, 49585, 49586, 49649, G22, G45, G47, G77, G83, G87X, G90X, R15, XP03, XP21, XP27, XP28, XP29 & XP32.

    Distribution

    Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy.

    Quantity

    75 units