Trackx Technology Inc 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
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
Brand
Trackx Technology Inc
Lot Codes / Batch Numbers
Insight Base -5L - Lot #2206001, exp. 6/1/2025, UDI 00857088008431, Insight Base 6.5L - Lot #2202002, exp. 2/1/20024, UDI 00857088008448.
Products Sold
Insight Base -5L - Lot #2206001, exp. 6/1/2025, UDI 00857088008431; Insight Base 6.5L - Lot #2202002, exp. 2/1/20024, UDI 00857088008448.
Trackx Technology Inc is recalling TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base due to The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
Recommended Action
Per FDA guidance
The recall was initiated via phone call on 10/24/2022 and 10/27/2022 (as well as subsequent in-person meetings) to two of the physicians who use the product in the affected application. The physicians were notified that the products can fragment when attached to a T-Handle and Nuvasive XLIF disectomy instruments while malleting and TrackX is limiting the use of those two bases to situations in the Nuvasive XLIF and Lateral Interbody procedures that do not require the malleting of the T-handle. The product is to be used in a limited manner and not on the Nuvasive T-Handle with Nuvasive XLIF Disectomy instruments. Letters dated 12/30/2022 began issuing via hand delivery or via DocuSign to all customers who have received the products. The letter informed the customer of the issue and said the IFU was revised with the application change and warning. The customer was informed that if they have further distributed or transferred the product to another location, they are to notify the recipients of the field action. A distribution list was provided to show the product that was shipped to the customer. An Acknowledgement and Receipt Form was enclosed along with the revised IFU (Warnings and Precautions section).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026