BEUDAMED
    FDA Recall Terminated

    Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089

    Recall: Z-0948-2008 · Initiated April 25, 2006

    Recall

    Recall Number
    Z-0948-2008
    Event Number
    39366
    Firm
    Kyphon Inc
    FEI Number
    3004904811
    Product Code
    BSP
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    April 25, 2006
    Posted
    February 5, 2008
    Terminated
    June 10, 2008
    Address
    1221 Crossman Ave, Sunnyvale, CA, 94089-1103

    Description

    Functional Anaesthetic Discography (F.A.D.) Catheter System, Catalog #: D01A, Kyphon, Inc., Sunnyvale, Ca 94089

    Reason

    Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.

    Action

    A customer advisory letter was sent on 4/25/06 to consignees. In some cases some were issued in person. Follow up with field representatives was also conducted. Both contacts involved providing IMPORTANT CHANGES IN INSTRUCTIONS FOR USE that are to be attached to the on site users documents. The recalling firm is updating future distribution with the new instructions for use.

    Distribution

    Nationwide including states of AL, AZ, CA, FL, IN, NH, NY, DC, ME, MD, WI, and PA.

    Quantity

    By Lot Number : J 6013102 = 147, Lot: J6033012 = 23