BEUDAMED
    FDA Recall 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 · Initiated March 11, 2015

    Recall

    Recall Number
    Z-1512-2015
    Event Number
    70774
    Firm
    X Spine Systems Inc
    FEI Number
    3005031160
    Product Code
    MNH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 11, 2015
    Posted
    April 22, 2015
    Terminated
    October 21, 2015
    Address
    452 Alexandersville Rd, Miamisburg, OH, 45342-3658

    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.

    Action

    The firm, X-spine Systems, Inc., sent an "Urgent Medical Device Recall" letter dated March 19, 2015 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to notify affected hospital and surgeon of the recall immediately; complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately via mail: 725 Alexandersville Road, Miamisburg OH 45342-RMA #5288; and No action should be taken with product that has been implanted. Please contact customer service at 800.903.0640 or email [email protected] with any questions.

    Distribution

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

    Quantity

    14 units