Trackx Technology Inc: TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.

Hazard

The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.

Details from the source

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. Distribution: US Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI. Quantity: 464 devices Lot/code info: Insight Base -5L - Lot #2206001, exp. 6/1/2025, UDI 00857088008431; Insight Base 6.5L - Lot #2202002, exp. 2/1/20024, UDI 00857088008448.

UPC codes

00857088008431, 00857088008448

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.