TrackX Insight Base Modular Instrument Tracker — Class II medical device recall Z-1107-2023
Terminated recall by Trackx Technology Inc, reported 2023-02-15, distributed nationwide. The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF inst
| Recall number | Z-1107-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Trackx Technology Inc, Hillsborough, NC, United States |
| Recall initiated | 2022-10-24 |
| Classified | 2023-02-09 |
| Reported by FDA | 2023-02-15 |
| Terminated | 2026-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 464 devices |
| UPC / GTIN / UDI-DI | 00857088008431, 00857088008448 |
| Lot numbers | 2/1/20024, 2202002, 2206001 |
| Model numbers | 604-3TX, 605-3TX |
| Expiration dates | 2025-06-01 |
Product
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
Reason for recall
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
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-1107-2023. 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.