Class III — Trackx Technology Inc
| Recalling firm | TrackX Technology Inc. |
|---|---|
| Registered facility | TRACKX TECHNOLOGY Inc. (the firm's only registered facility) |
| Classification | Class III |
| Status | Ongoing |
| 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. |
| 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 surg… |
| Quantity | 82 |
| Distribution | NC, VA, FL, PA, NY |
| Initiated | 2024-09-03 |
| Classified | 2024-10-30 |
| Recall number | Z-0260-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Trackx Technology Inc (Z-0260-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95424/
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