FDA recall Z-1107-2023

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.

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.

Key facts

Status

Ongoing

Initiation date

2022-10-24

Report date

2023-02-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hillsborough, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1107-2023