BEUDAMED
    FDA Recall Terminated

    Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, REF 7961814; 16MM, REF 7961816; 18MM, REF 7961818; 20MM, REF 7961820; Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.

    Recall: Z-1796-2009 · Initiated February 6, 2009

    Recall

    Recall Number
    Z-1796-2009
    Event Number
    52125
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 6, 2009
    Posted
    July 24, 2009
    Terminated
    April 19, 2010
    Address
    1800 Pyramid Place, Memphis, TN, 38132

    Description

    Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, REF 7961814; 16MM, REF 7961816; 18MM, REF 7961818; 20MM, REF 7961820; Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.

    Reason

    The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.

    Action

    Medtronic Sofamor Danek USA, Inc. instructed Sales Representative on starting February 6, 2009 by phone to immediately return product from the field. The firm further issued a "Subject: Medtronic Intrepid Intervertebral Body Fusion Device Recall" notice dated April 2009. The recall notices were mailed directly to Risk Managers and Surgeons, with Recall Questionnaires and Surgeon Confirmation forms included respectively. For further questions, contact your Medtronic Sales Representative or the Medtronic Global Quality Department at 1-800-876-3133 extension 6333.

    Distribution

    Worldwide Distribution -- United States, Australia, Germany, The Netherlands, and South Africa.

    Quantity

    637 units