Reported Feb 15, 2023 · Ongoing
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument…
Trackx Technology Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Trackx Technology Inc · 437 Dimmocks Mill Rd Ste 28 · Hillsborough, NC · 27278-2379
Is this the product you have?
- TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
- Lot codes and dates
Insight Base -5L - Lot #2206001exp. 6/1/2025UDI 00857088008431Insight Base 6.5L - Lot #2202002exp. 2/1/20024UDI 00857088008448
- Amount recalled
- 464 devices
Where it was sold
Why it was recalled
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
This product could cause temporary or reversible health problems — stop using it.
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