FDA Medical Device Recalls (openFDA)
Trackx Technology Inc: 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.
- Recall number
- Z-0260-2025
- Recalling firm
- Trackx Technology Inc
- 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.
- Status
- Open, Classified
- Initiated
- 2024-09-03
- Posted
- 2024-10-30
- Terminated
- not on file
- 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.
- Root cause
- Error in labeling
- Action
- TrackX Technology issued an Urgent: Medical Device Field Correction notice to its consignees via hand delivery by their sales representatives on 10/01/2024. The notice explained the issue and requested that the notice be provided to all parties to whom the product was distributed. The sales representatives exchanged the affected product for correctly labeled product.
- Quantity
- 82
- Distribution
- NC, VA, FL, PA, NY
- Lot, serial or model codes
- GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027
- 510(k) numbers
- ["K173736","K200360"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3014391847
- Firm city
- Hillsborough
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28