BEUDAMED
    FDA Enforcement Class II 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 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2200-2013
    Event ID
    66010
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 25, 2013
    Initiation Date
    August 12, 2013
    Classification Date
    September 14, 2013
    Termination Date
    December 27, 2013
    Address
    1800 Pyramid Place, N/A, Memphis, TN, 38132, United States

    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.

    Code Info

    RS12K008

    Distribution

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

    Quantity

    9 units