Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Product Name: Insight Base Flex - 8 Recalled by Trackx Technology Inc Due to The patient label stickers may have the wrong...

Date: September 3, 2024
Company: Trackx Technology Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Trackx Technology Inc directly.

Affected Products

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.

Quantity: 82

Why Was This 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.

Where Was This Sold?

This product was distributed to 5 states: FL, NY, NC, PA, VA

Affected (5 states)Not affected

About Trackx Technology Inc

Trackx Technology Inc has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report