BEUDAMED
    FDA Enforcement Class II Terminated

    Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.

    Recall: Z-1512-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1512-2015
    Event ID
    70774
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    X Spine Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    March 11, 2015
    Classification Date
    April 22, 2015
    Termination Date
    October 21, 2015
    Address
    452 Alexandersville Rd, Miamisburg, OH, 45342-3658, United States

    Description

    Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies.

    Reason

    One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.

    Code Info

    Lot #: 4084-01; M/N X073-5555; UDI: *+M697X07355551/$408401U*

    Distribution

    US Distribution to states of: KS, NV & TX.

    Quantity

    14 units