Recall Z-0260-2025— Trackx Technology Inc

Name: FDA recall Z-0260-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-03

Class III · Ongoing

Class III FDA medical device recall by Trackx Technology Inc, initiated 2024-09-03. It names 2 FDA 510(k) clearances: K200360, K173736. Product: 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 used with a compatible tracking system. Each TrackX¿ Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.. 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..

Recalling firm: Trackx Technology Inc
Classification: Class III
Status: Ongoing
Initiated: 2024-09-03
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

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 used with a compatible tracking system. Each TrackX¿ Snap has a unique set of 2 or more reflective markers. By having unique configurations of reflective markers, it is possible to identify which TrackX Snap is in the field of view of the camera(s). As such, it is also possible to have multiple TrackX Snaps in the field at once and to have different TrackX Snaps for different surgical instruments. The device is considered to be a sterile accessory.

Reason for recall

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.

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