BEUDAMED
    FDA Recall Terminated

    Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON LEGACY" Percutaneous Peek Spinal System

    Recall: Z-0606-2010 · Initiated December 7, 2009

    Recall

    Recall Number
    Z-0606-2010
    Event Number
    54031
    Firm
    Medtronic Sofamor Danek USA Inc
    FEI Number
    1000477302
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 7, 2009
    Posted
    January 12, 2010
    Terminated
    January 14, 2011
    Address
    1800 Pyramid Place, Memphis, TN, 38132

    Description

    Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON LEGACY" Percutaneous Peek Spinal System

    Reason

    The Trocar may not fully engage with the Rod Inserter or may prematurely disengage.

    Action

    On 12/7/2009, the Sales Representatives were notified by conference call and email regarding the recall. The recall notices were mailed directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included respectively, on 12/09/2009 with a delivery date of 12/10/09.

    Distribution

    Nationwide distribution, and the Netherlands

    Quantity

    199 units