BEUDAMED
    FDA Recall Terminated

    Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.

    Recall: Z-1427-2013 · Initiated September 19, 2011

    Recall

    Recall Number
    Z-1427-2013
    Event Number
    65083
    Firm
    Intuitive Surgical, Inc.
    FEI Number
    3001675293
    Product Code
    NAY
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    September 19, 2011
    Posted
    May 29, 2013
    Terminated
    May 30, 2013
    Address
    1266 Kifer Rd, Bldg 100, Sunnyvale, CA, 94086-5304

    Description

    Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.

    Reason

    Clarification of existing labeling information and operating procedures.

    Action

    Intuitive Surgical sent an "IMPORTANT PRODUCT NOTIFICATION" letter dated October 17, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 1-800-876-1310 for questions regarding this notice.

    Distribution

    Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.

    Quantity

    NA