Device 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.
Z-0260-2025
Product summary
- Event
- Event 95424
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 82
- Official record key
device-enforcement:Z-0260-2025
Official wording
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.
Code information: GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027
Distribution pattern: NC, VA, FL, PA, NY
Derived failure modes
-
Labeling or packaging
label stickers may have the wrong