TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Ba...
FDA Recall #Z-1107-2023 — Class II — October 24, 2022
Product 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 for Recall
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
Recalling Firm
Trackx Technology Inc — Hillsborough, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
464 devices
Distribution
US Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI.
Code Information
Insight Base -5L - Lot #2206001, exp. 6/1/2025, UDI 00857088008431; Insight Base 6.5L - Lot #2202002, exp. 2/1/20024, UDI 00857088008448.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.