Trackx Technology Inc: Medical Device Recall in 2024 - (Recall #: Z-0260-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: September 3, 2024

Date Posted: November 6, 2024

Recall Number: Z-0260-2025

Event ID: 95424

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.

Status: Ongoing

Product Quantity: 82

Code Information:

GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027

Distribution Pattern:

NC, VA, FL, PA, NY

Voluntary or Mandated:

Voluntary: Firm initiated