Device 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.
Z-1107-2023
Product summary
- Event
- Event 91338
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 464 devices
- Official record key
device-enforcement:Z-1107-2023
Official wording
Reason: The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.
Code information: Insight Base -5L - Lot #2206001, exp. 6/1/2025, UDI 00857088008431; Insight Base 6.5L - Lot #2202002, exp. 2/1/20024, UDI 00857088008448.
Distribution pattern: US Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI.
Derived failure modes
-
Unknown
The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted.