BEUDAMED
    FDA Recall Terminated

    Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R

    Recall: Z-0352-2018 · Initiated December 6, 2017

    Recall

    Recall Number
    Z-0352-2018
    Event Number
    78790
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    OAR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 6, 2017
    Terminated
    November 4, 2019
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703

    Description

    Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R

    Reason

    Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.

    Action

    Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees on 06 DEC 2017. The recall notice stated the following: "If he/she has not already done so, your Sales Representative will contact you to facilitate the return of any impacted products you may have in your possession. Please disseminate this information to additional personnel within your facility as appropriate, and maintain a copy of this notice in your records. Instructions to Customers: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product."

    Distribution

    US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US

    Quantity

    3,319 units