FDA-Device2023-02-15Class II
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
Trackx Technology Inc
Hazard
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
Sold states
US Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI.
Affected count
464 devices
Manufactured in
437 Dimmocks Mill Rd Ste 28, Hillsborough, NC, United States
Products
TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1107-2023Don't want to check this manually?
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