BEUDAMED
    FDA Recall Terminated

    8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

    Recall: Z-0660-2007 · Initiated March 24, 2005

    Recall

    Recall Number
    Z-0660-2007
    Event Number
    37436
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 24, 2005
    Posted
    March 28, 2007
    Terminated
    November 28, 2007
    Address
    950 Kifer Rd, Sunnyvale, CA, 94086-5206

    Description

    8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA

    Reason

    The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses.

    Action

    The firm initiated its recall in March 24, 2005, when the firm sent a letter via Federal Express mail to all 18 consignees, informing them of the issue, how to identify affected product, and instructions to return the affected instruments for a full credit. The form included a reply form that consignees were requested to fill out and return.

    Distribution

    Product was distributed to 12 consignees in the US, who received 19 instruments, in FL, IN, LA, MN, NC, NH, NJ, NY, TN and TX. In addition, 5 consignees outside the US received product as well, in Italy, Sweden, France, Singapore and Germany.

    Quantity

    8