Recall Z-1107-2023— Trackx Technology Inc

Name: FDA recall Z-1107-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-24

Class II · Ongoing

Class II FDA medical device recall by Trackx Technology Inc, initiated 2022-10-24. It names 2 FDA 510(k) clearances: K200360, K173736. 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: The device is breaking and falling off the Nuvasive T-Handle with Hudson Adapter on certain Nuvasive XLIF instruments during surgery when malleted..

Recalling firm: Trackx Technology Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-10-24
Firm location: Hillsborough, NC, United States

510(k) clearances named in this recall

2 on FDA's record

K200360 — TrackXTrack X Technology, LLC·cleared 2020-03-05
K173736 — TrackXTrack X Technology, LLC·cleared 2018-02-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.