BEUDAMED
    FDA Recall Terminated

    Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide, Rx Only,

    Recall: Z-1912-2008 · Initiated March 1, 2008

    Recall

    Recall Number
    Z-1912-2008
    Event Number
    48070
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LGW
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    March 1, 2008
    Posted
    September 16, 2008
    Terminated
    June 5, 2012
    Address
    800 53rd Ave NE PO Box 1250, Minneapolis, MN, 55440-1250

    Description

    Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide, Rx Only,

    Reason

    Medtronic Model 3777-75 Octad 1x8 Leads, Lot V030733 contain accessory stylets that are not the correct length.

    Action

    Consignees were sent a Medtronic Letter dated March 2008. The letter described the product model / serial number and problem. It gave the option in assisting in returning the product for replacement or credit. A Medtronic Inter-Office Memo was also issued to "Affected Field Personnel" . The memo described the product /problem and the action required . Contact Medtronic Neuromodulation Quality at 651-367-0628 if you have questions.

    Distribution

    NC, FL

    Quantity

    3