BEUDAMED
    FDA Recall Terminated

    Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer CW-USLRBP CyberWand USL Renal/Bladder Probe Set CW-USLTT CyberWand USL Transducer Sterilization Tray

    Recall: Z-1073-2007 · Initiated May 23, 2007

    Recall

    Recall Number
    Z-1073-2007
    Event Number
    37999
    Firm
    Gyrus ACMI Corporation
    FEI Number
    3003790304
    Product Code
    FFK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 23, 2007
    Posted
    August 9, 2007
    Terminated
    May 25, 2010
    Address
    136 Turnpike Road, Southborough, MA, 01772-2118

    Description

    Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer CW-USLRBP CyberWand USL Renal/Bladder Probe Set CW-USLTT CyberWand USL Transducer Sterilization Tray

    Reason

    Sterilization Instructions not adequate for sterilizing.

    Action

    Gyrus has informed their sales force to visit each customer that has a CyberWand system(s) and hand deliver a letter, dated May 23, 2007, that explains the situation and requests that the customer cease using the unit and segregate it to prevent accidental use. The letter also explains that the firm is collecting any sterilization trays with printed sterilization instructions and replacing them. The rep will assist the customer in complying. The customer will also be required to complete a reply form to track compliance.

    Distribution

    Nationwide and Canada.

    Quantity

    53 units