TrackX Insight Base Modular Instrument Tracker, 5L, REF… recallZ-1107-2023 · Trackx Technology Inc · initiated Oct 24, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Trackx Technology Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
FDA root cause category: Device Design
What the company is doing
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).
Recall details
- Recall number
- Z-1107-2023
- Status
- Terminated
- Initiated by the company
- Oct 24, 2022
- Posted by the FDA
- Feb 9, 2023
- Recalling firm
- Trackx Technology Inc
- Quantity
- 464 devices
- Product code
- OWB
- FDA submissions
- K200360, K173736
- Distribution
- US Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI.
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.
Code information (models, lots, serial numbers)
Insight Base -5L - Lot #2206001, exp. 6/1/2025, UDI 00857088008431; Insight Base 6.5L - Lot #2202002, exp. 2/1/20024, UDI 00857088008448.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- TrackX INSIGHT™ BASE-5LTrackX Technology, LLC · Interventional Fluoroscopic X-Ray System1 recall0 reports
- TrackX INSIGHT™ BASE-6.5LTrackX Technology, LLC · Interventional Fluoroscopic X-Ray System1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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