Z-1107-2023 Class II Terminated
FDA device recall Z-1107-2023 was initiated by Trackx Technology Inc on October 24, 2022 and is designated Class II. 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. The recall status is terminated (terminated September 10, 2026). Affected quantity: 464 devices.
Recall Details
- Product Type
- Devices
- Report Date
- February 15, 2023
- Initiation Date
- October 24, 2022
- Termination Date
- September 10, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 464 devices
Product Description
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 Pattern
US Nationwide distribution in the states of AZ, FL, LA, NC, PA, VA, WA, WI.
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.