Trackx Technology Inc recalls Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective featur…

Recall date

September 3, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0260-2025

FDA classification

Class III

Brand / firm

Trackx Technology Inc

Sold / distributed

NC, VA, FL, PA, NY

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.