BEUDAMED
    FDA Enforcement Class III Ongoing

    Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX¿ Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.

    Recall: Z-0260-2025 · Reported November 6, 2024

    Enforcement

    Recall Number
    Z-0260-2025
    Event ID
    95424
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Trackx Technology Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 6, 2024
    Initiation Date
    September 3, 2024
    Classification Date
    October 30, 2024
    Address
    437 Dimmocks Mill Rd Ste 28, N/A, Hillsborough, NC, 27278-2379, United States

    Description

    Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX¿ Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.

    Reason

    The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration date of the product is 2027-04-01. This is reflected on the carton label and sterile pouch label correctly.

    Code Info

    GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027

    Distribution

    NC, VA, FL, PA, NY

    Quantity

    82