Class 2 Device Recall TrackX

• Date Initiated by Firm: October 24, 2022
• Date Posted: February 09, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1107-2023
• Recall Event ID: 91338
• 510(K)Number: K173736 K200360
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• 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.
• 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.
• FEI Number: 3014391847
• Recalling Firm/ Manufacturer: Trackx Technology Inc; 437 Dimmocks Mill Rd Ste 28; Hillsborough NC 27278-2379
• For Additional Information Contact: Frederick Cole; 209-403-3160
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB