Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective feature
Summary
The FDA issued a Class III for Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a steri by Trackx Technology Inc. Reason: The patient label stickers may have the wrong expiration date recorded. The contract manufacturer entered the manufacturing date (2024-04-01) as the e.
Details
Source
Device Recall
External ID
Z-0260-2025
Action Date
2024-11-06
Status
Ongoing
Category
device
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.
Lot/Code Info: GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027
Quantity Affected: 82
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.
Distribution
NC, VA, FL, PA, NY
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-03
Company
Hillsborough, NC
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Trackx Technology Inc has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Trackx Technology Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Trackx Technology Inc have FDA actions?
Trackx Technology Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0260-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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