BEUDAMED
    FDA Recall Terminated

    Medtronic Accessory Kit , Titan Anchor Accessory Kit, 3550-39, Single Use, RX Only, Contents of the inner package are STERILE., Medtronic, Inc, Minneapolis, MN 55432-5604

    Recall: Z-0500-2010 · Initiated October 27, 2009

    Recall

    Recall Number
    Z-0500-2010
    Event Number
    53689
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LGW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 27, 2009
    Posted
    December 11, 2009
    Terminated
    December 24, 2011
    Address
    7000 Central Ave NE, Minneapolis, MN, 55432-3568

    Description

    Medtronic Accessory Kit , Titan Anchor Accessory Kit, 3550-39, Single Use, RX Only, Contents of the inner package are STERILE., Medtronic, Inc, Minneapolis, MN 55432-5604

    Reason

    Medtronic is issuing a medical device correction for the Model 3550-39 Titan anchor due to the potential for lead migration as a result of insert separation within the anchor. The Medtronic Model 3550-39 Titan anchor accessory kit is designed for use with Medtronic percutaneous in-line connector spinal cord stimulation leads. Medtronic has received reports of separation of the titanium insert

    Action

    Consignees were sent a Medtronic "Urgent: Medical Device Correction" letter on 10/27/09. The letter was addressed to "Dear Healthcare Professional" and was dated October 2009. The letter described the problem and the product as well as the Scope and Potential Severity and gave Recommendations. Enclosures with the letter included: Use By Date (UBD) location on the Titan anchor accessory kit product packaging, Titan anchor patient letter, Reply card and Return envelope. Questions are direct to Medtronic via email at [email protected].

    Distribution

    All states in the United States including Puerto Rico. Australia, New Zealand, Canada, Andurra, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Netherlands, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, Tukey, United Kingdom.

    Quantity

    55,600