Product Name: Insight Base Flex — Class III medical device recall Z-0260-2025
Ongoing recall by Trackx Technology Inc, reported 2024-11-06, distributed in FL, NC, NY, PA, VA. The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the
| Recall number | Z-0260-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trackx Technology Inc, Hillsborough, NC, United States |
| Recall initiated | 2024-09-03 |
| Classified | 2024-10-30 |
| Reported by FDA | 2024-11-06 |
| Distributed | FL, NC, NY, PA, VA |
| Quantity | 82 |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 00857088008493 |
| Lot numbers | 2404002 |
| Model numbers | 608-3TX |
| Expiration dates | 2027-04-01 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0260-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.