CLASS II Device recall · Reported 15 Feb 2023 · FDA Enforcement Report
TrackX Insight Base Modular Instrument Tracker recalled
Trackx Technology is recalling TrackX Insight Base Modular Instrument Tracker, distributed nationwide in the US. The recall was initiated on 24 Oct 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1107-2023
- FDA event ID
- 91338
- Recalling firm
- Trackx Technology, Hillsborough, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Oct 2022
- FDA classified
- 9 Feb 2023
- Reported
- 15 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 24 Oct 2022 | Recall initiated by company | |
| 9 Feb 2023 | Classified by FDA | +108 days |
| 15 Feb 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
Where it was distributed
US Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI.
Nationwide ArizonaFloridaLouisianaNorth CarolinaPennsylvaniaVirginiaWashingtonWisconsin
Questions about this recall
Why was it recalled?
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
Which lots are affected?
Insight Base -5L - Lot #2206001, exp. 6/1/2025, UDI 00857088008431; Insight Base 6.5L - Lot #2202002, exp. 2/1/20024, UDI 00857088008448.
Where was it sold?
US Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Trackx Technology
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|---|---|---|---|---|---|
| Device | CLASS III | Insight Base Flex recalled by Trackx Technology | Trackx Technology | Sterility | 5 states |
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