FDAFDA · Food and drugs·Recall number Z-0260-2025
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.
Published November 6, 2024 · Recall initiated: September 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Trackx Technology Inc
- Distributor
- NC, VA, FL, PA, NY
- Lot
- GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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