BEUDAMED
    FDA Enforcement Class II Ongoing

    TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.

    Recall: Z-1107-2023 · Reported February 15, 2023

    Enforcement

    Recall Number
    Z-1107-2023
    Event ID
    91338
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Trackx Technology Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 15, 2023
    Initiation Date
    October 24, 2022
    Classification Date
    February 9, 2023
    Address
    437 Dimmocks Mill Rd Ste 28, Hillsborough, NC, 27278-2379, United States

    Description

    TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.

    Reason

    The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.

    Code Info

    Insight Base -5L - Lot #2206001, exp. 6/1/2025, UDI 00857088008431; Insight Base 6.5L - Lot #2202002, exp. 2/1/20024, UDI 00857088008448.

    Distribution

    US Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI.

    Quantity

    464 devices