# FDA recall Z-0260-2025

> **Trackx Technology Inc** · Class III · device recall initiated 2024-09-03.

## 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.

## 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.

## Distribution

NC, VA, FL, PA, NY

## Key facts

- **Recall number:** Z-0260-2025
- **Recalling firm:** Trackx Technology Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-03
- **Report date:** 2024-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hillsborough, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0260-2025

## Citation

> AI Analytics. FDA recall Z-0260-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-0260-2025. Source: US FDA. Licensed CC0.

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