Z-0260-2025Class III

Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes...

Name: Z-0260-2025 Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes...
Creator: Trackx Technology Inc
Published: 2024-09-03
License: https://open.fda.gov/license/

TRACKX TECHNOLOGY Inc. / initiated 2024-09-03 / Open, Classified / root cause: labeling and UDI

FDA source

Trackx Technology Inc began a recall of 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... on 2024-09-03. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0260-2025
Classification: Class III
Status: Open, Classified
Initiated: 2024-09-03
Posted: 2024-10-30
Recalling firm: TRACKX TECHNOLOGY Inc.
Product: 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.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 82
Distribution: NC, VA, FL, PA, NY
Product codes and lots: GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0260-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0260-2025	Class III	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30

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)