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Trackx Technology Inc recalls TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument T
Recalled February 15, 2023 · FDA recall Z-1107-2023 · Trackx Technology
Hazard
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted. · FDA Class II
Units
464 devices
Sold at
US Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI.
Description
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
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.
Manufacturer(s)
Trackx Technology Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →