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U.S. Department of Health and Human Services

Class 3 Device Recall TRACKX Insight Base Flex

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 Class 3 Device Recall TRACKX Insight Base Flexsee related information
Date Initiated by FirmSeptember 03, 2024
Date PostedOctober 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0260-2025
Recall Event ID 95424
510(K)NumberK173736 K200360 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductProduct 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.
Code Information GTIN: 00857088008493, Lot: 2404002, Expiration Date: 04/01/2027
FEI Number 3014391847
Recalling Firm/
Manufacturer		 Trackx Technology Inc
437 Dimmocks Mill Rd Ste 28
Hillsborough NC 27278-2379
For Additional Information ContactFrederick Cole
1-209-4033160
Manufacturer 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.
FDA Determined
Cause 2		Error in labeling
ActionTrackX 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 in Commerce82
DistributionNC, VA, FL, PA, NY
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OWB
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