BEUDAMED
    FDA Recall Terminated

    CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 implantation

    Recall: Z-0465-2012 · Initiated November 30, 2011

    Recall

    Recall Number
    Z-0465-2012
    Event Number
    60568
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    November 30, 2011
    Posted
    January 11, 2012
    Terminated
    April 5, 2012
    Address
    1800 Pyramid Place, Memphis, TN, 38132

    Description

    CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 implantation

    Reason

    One screw may be longer then size etched on the screw.

    Action

    Medtronic Sofamor Danek USA, Inc sent a Voluntary Field Correction letter dated November 30, 2011, via FedEx to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The firm will visit each consignee to perform a visual check of inventory. Please utilize the attached questionnare to account for the affected product and to record any patient injuries that may have occurred specifically related to the use of these items. If you need assistance, or if you have any related questions or concerns please call (800) 876-3133 extension 3173

    Distribution

    Nationwide Distribution including the states of AL, PA, IN, CO, MI and IA.

    Quantity

    30 units