FDA Device recall Z-0260-2025
Product Name: Insight Base Flex - 8, Ref 608-3TX
- FDA Device
- Class III
- ongoing
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class III recall of Product Name: Insight Base Flex - 8, Ref 608-3TX by Trackx Technology, citing 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 ex….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0260-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-09-03 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Trackx Technology |
| Distribution | FL, NC, NY, PA, VA |
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
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.
Identifiers
| code_info | GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0260-2025%22
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