BEUDAMED
    FDA Recall 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 · Initiated April 7, 2015

    Recall

    Recall Number
    Z-1823-2015
    Event Number
    71357
    Firm
    X Spine Systems Inc
    FEI Number
    3005031160
    Product Code
    MNH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 7, 2015
    Posted
    June 22, 2015
    Terminated
    October 1, 2015
    Address
    452 Alexandersville Rd, Miamisburg, OH, 45342-3658

    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.

    Action

    X-Spine sent an Urgent Medical Device Recall Letter dated April 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: 1. The affected hospital and surgeon should be notified of this recall immediately. 2. Complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately. a. Reference RMA # 5410 b. Use enclosed shipping label 3. No action should be taken with product that has been implanted. Please feel free to contact me at 800.903.0640 ext. 137.

    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