Product Name: Insight Base Flex - 8, Ref 608-3TX recallZ-0260-2025 · Trackx Technology Inc · initiated Sep 3, 2024
Open, Classified
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 patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration date of the product is 2027-04-01. This is reflected on the carton label and sterile pouch label correctly.
FDA root cause category: Error in labeling
What the company is doing
TrackX Technology issued an Urgent: Medical Device Field Correction notice to its consignees via hand delivery by their sales representatives on 10/01/2024. The notice explained the issue and requested that the notice be provided to all parties to whom the product was distributed. The sales representatives exchanged the affected product for correctly labeled product.
Recall details
- Recall number
- Z-0260-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 3, 2024
- Posted by the FDA
- Oct 30, 2024
- Recalling firm
- Trackx Technology Inc
- Quantity
- 82
- Product code
- OWB
- FDA submissions
- K173736, K200360
- Distribution
- NC, VA, FL, PA, NY
Product description
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.
Code information (models, lots, serial numbers)
GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TrackX INSIGHT™ BASE FLEX-8TrackX 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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