The Recall Desk
ModerateFDA (Devices)·Z-0260-2025·Announced 2024-11-06

Surgical tracking device patient labels show incorrect expiration date

Patient label stickers on Insight Base Flex tracking device snaps have incorrect expiration dates. The stickers show manufacturing date instead of actual expiration date, though the correct date appears on carton and pouch labels.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class III recall with minor labeling error: patient label stickers show incorrect expiration date (manufacturing date instead of actual date). Correct dates appear on carton and sterile pouch labels. No illnesses or injuries reported.

Plain-English summary

Trackx Technology Inc is recalling Insight Base Flex - 8 (Ref 608-3TX) surgical instrument tracking device snaps because patient label stickers contain incorrect expiration dates. The contract manufacturer mistakenly recorded the manufacturing date (April 1, 2024) as the expiration date instead of the actual expiration date (April 1, 2027). However, the correct expiration date is properly displayed on the carton label and sterile pouch label.

The recall affects 82 units with GTIN 00857088008493, Lot 2404002 distributed in North Carolina, Virginia, Florida, Pennsylvania, and New York.

Consumers and healthcare providers who have received these devices should verify the expiration date by checking the carton or sterile pouch label rather than relying on the patient label sticker. Contact Trackx Technology Inc if you have questions about your device.

The recalled product

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
Manufacturer
Trackx Technology Inc
Hazard
  • mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • GTIN: 00857088008493
  • Lot: 2404002
  • Expiration Date: 04/01/2027

Distribution

Distributed in 5 states:

  • FL
  • NC
  • NY
  • PA
  • VA