BEUDAMED
    FDA Recall Terminated

    Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.

    Recall: Z-0125-2008 · Initiated September 10, 2007

    Recall

    Recall Number
    Z-0125-2008
    Event Number
    44854
    Firm
    Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
    FEI Number
    1824199
    Product Code
    KWP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 10, 2007
    Posted
    February 7, 2008
    Terminated
    July 14, 2009
    Address
    2500 Silveus Crossing, Warsaw, IN, 46582-8598

    Description

    Medtronic Sofamor Danek COLORADO 2" SPINAL SYSTEM Break-Off Nut, non-sterile, RX; Catalog Number 8634111, Medtronic, Memphis, TN 38138.

    Reason

    Assembly may be compromised: Two thread grooves are missing on the nut, which may cause damage to the bone screw and result in the need for the bone screw to be replaced.

    Action

    Medtronic Sofamor Danek notified consignees by Urgent Device Recall letter dated 9/10/07 to immediately cease using the product and to return the devices with a Product Recall Questionnaire, recording quantity of devices and any patient injuries.

    Distribution

    Worldwide Distribution - USA, Australia, Hong Kong and the Netherlands.

    Quantity

    2,569