BEUDAMED
    FDA Enforcement Class II Ongoing

    Mazor X robotic guidance system REF: TPL0059

    Recall: Z-1122-2026 · Reported January 28, 2026

    Enforcement

    Recall Number
    Z-1122-2026
    Event ID
    98199
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mazor Robotics Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 28, 2026
    Initiation Date
    December 10, 2025
    Classification Date
    January 16, 2026
    Address
    North Industrial Park, 5, Shakham, Caesarea, N/A, Israel

    Description

    Mazor X robotic guidance system REF: TPL0059

    Reason

    Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

    Code Info

    Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, China, Croatia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Vietnam.

    Quantity

    549 systems