BEUDAMED
    FDA Recall Terminated

    Precision Implantable Pulse Generator (IPG), Model Number SC-110

    Recall: Z-0055-2008 · Initiated August 3, 2007

    Recall

    Recall Number
    Z-0055-2008
    Event Number
    39383
    Firm
    Advanced Bionics Corp
    FEI Number
    1000220815
    Product Code
    LGW
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    August 3, 2007
    Posted
    October 12, 2007
    Terminated
    January 25, 2012
    Address
    12740 San Fernando Rd, Sylmar, CA, 91342-3728

    Description

    Precision Implantable Pulse Generator (IPG), Model Number SC-110

    Reason

    Mislabeled: Product labeled with the incorrect shelf-life information.

    Action

    There was one unit affected by this field action. An Advanced Bionics representative contacted and visited the facility on August 3, 2007. At this time, the affected device has been retrieved by the Company.

    Distribution

    MD

    Quantity

    1 unit affected