Hillsborough, NC, United States
Trackx Technology Inc recalls
2 recalls recorded since 2018, most recently on 3 September 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class III Medical devices
- Recall started
- 3 September 2024
- Reason
- The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date. The actual expiration date of the product is 2027-04-01. This is reflected on the carton label and sterile pouch label correctly.
- Distribution
- NC, VA, FL, PA, NY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0260-2025
- Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when use
Terminated Class II Medical devices
- Recall started
- 24 October 2022
- Terminated
- 10 September 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1107-2023
- TrackX Insight Base Modular Instrument Tracker, 5L, REF #604-3TX, Sterile; and TrackX Insight Base Modular Instrument Tracker, 6.5L, Model #605-3TX, Sterile.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.