BEUDAMED
    FDA Recall Terminated

    T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.

    Recall: Z-2200-2013 · Initiated August 12, 2013

    Recall

    Recall Number
    Z-2200-2013
    Event Number
    66010
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    HXX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 12, 2013
    Posted
    September 14, 2013
    Terminated
    December 27, 2013
    Address
    1800 Pyramid Place, Memphis, TN, 38132

    Description

    T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.

    Reason

    One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.

    Action

    Medtronic sent an Urgent Voluntary Market Removal Recall letter dated August 9, 2013 with Recall Questionnaires and Confirmation forms included to Risk Managers and Sales Representatives. The letter identified the affected product, problem and action to be taken. Customers were instructed to remove the affected product, discontinue use and contact your Medtronic Sales Representative to coordinate the return and replenishment of affected product. For questions call your Medtronic Sales Representative or Global Quality Department at 800-876-3133.

    Distribution

    USA Nationwide Distribution in the state of GA, AK, WA, and CA.

    Quantity

    9 units