BEUDAMED
    FDA Recall Terminated

    KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.

    Recall: Z-2247-2017 · Initiated May 17, 2017

    Recall

    Recall Number
    Z-2247-2017
    Event Number
    77352
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    OAR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 17, 2017
    Terminated
    June 18, 2019
    Address
    1800 Pyramid Pl, Memphis, TN, 38132-1703

    Description

    KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.

    Reason

    The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon.

    Action

    Medtronic distributed a voluntary removal notice (Attachment I) via FedEx courier service to impacted U.S. consignees on 17 May 2017. Communications to impacted consignees outside the United States are currently ongoing per each geographies local procedures. The consignees were directed to do the following: 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 via fax to 763-367-8134, or via e-mail to [email protected]. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product.

    Distribution

    worldwide

    Quantity

    17657 units