FDA Device recall Z-1107-2023
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile
- FDA Device
- Class II
- completed
- Published 2023-02-15
On 2023-02-15 the FDA classified a Class II recall of TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile by Trackx Technology, citing the device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1107-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-10-24 |
| Published | 2023-02-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Trackx Technology |
| Distribution | US |
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
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
Identifiers
| code_info | Insight Base -5L - Lot #2206001, exp. 6/1/2025, UDI 00857088008431; Insight Base 6.5L - Lot #2202002, exp. 2/1/20024, UDI 00857088008448. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1107-2023%22
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