Z-1107-2023Class II

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

Name: Z-1107-2023 TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular...
Creator: Trackx Technology Inc
Published: 2022-10-24
License: https://open.fda.gov/license/

TRACKX TECHNOLOGY Inc. / initiated 2022-10-24 / Open, Classified / root cause: design

FDA source

Trackx Technology Inc began a recall of TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile on 2022-10-24. FDA classified it as Class II and gives the reason as "The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1107-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-24
Posted: 2023-02-09
Recalling firm: TRACKX TECHNOLOGY Inc.
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.
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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).
Quantity in commerce: 464 devices
Distribution: US Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI.
Product codes and lots: Insight Base -5L - Lot #2206001, exp. 6/1/2025, UDI 00857088008431; Insight Base 6.5L - Lot #2202002, exp. 2/1/20024, UDI 00857088008448.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1107-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1107-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-15	2023-02-09

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)