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 #2206001
    • exp. 6/1/2025
    • UDI 00857088008431
    • Insight Base 6.5L - Lot #2202002
    • exp. 2/1/20024
    • UDI 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.