Class II — Trackx Technology Inc
| Recalling firm | TrackX Technology Inc. |
|---|---|
| Registered facility | TRACKX TECHNOLOGY Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted. |
| 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. |
| Quantity | 464 devices |
| Distribution | US Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI. |
| Initiated | 2022-10-24 |
| Classified | 2023-02-09 |
| Terminated | 2026-09-10 |
| Recall number | Z-1107-2023 |
| 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 II recall — Trackx Technology Inc (Z-1107-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91338/
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