Reported Nov 6, 2024 · Ongoing
Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective…
Trackx Technology Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Trackx Technology Inc · 437 Dimmocks Mill Rd Ste 28 · Hillsborough, NC · 27278-2379
Is this the product you have?
- Product NameInsight 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 codes and dates
- GTIN00857088008493
- Lot2404002
- Expiration Date04/01/2027
- Amount recalled
- 82
Where it was sold
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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