BEUDAMED
    FDA Enforcement Class II Ongoing

    8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309

    Recall: Z-0865-2025 · Reported January 22, 2025

    Enforcement

    Recall Number
    Z-0865-2025
    Event ID
    95938
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Intuitive Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2025
    Initiation Date
    December 19, 2024
    Classification Date
    January 10, 2025
    Address
    1266 Kifer Rd, Sunnyvale, CA, 94086-5304, United States

    Description

    8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309

    Reason

    Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

    Code Info

    Model Number: 470309 Part Number: 470309-15 UDI-DI code: 00886874112434 Batch Numbers: K10230217 Model Number: 470309 Part Number: 470309-17 UDI-DI code: 00886874112410 Batch Numbers: K10230302

    Distribution

    U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam

    Quantity

    12