Trackx recalls Insight Base Flex - 8 devices with incorrect expiration date labels on patient stickers. The label shows 2024-04-01 instead of the actual 2027-04-01 expiration date. Affected units may pose a risk if used beyond expiration.
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.
Trackx is recalling Insight Base Flex - 8 surgical devices because patient label stickers show the wrong expiration date (2024-04-01 instead of 2027-04-01). This could lead to using expired products during surgery, potentially causing complications.
The patient label stickers incorrectly show the manufacturing date (2024-04-01) as the expiration date. The actual expiration date is 2027-04-01, which is reflected correctly on the carton and sterile pouch labels. Using expired products could lead to compromised sterility or effectiveness.
Surgical staff using Trackx Insight Base Flex - 8 devices with the specific lot number 2404002 are most at risk if they use the product beyond its actual expiration date.
Check for the lot number 2404002 on the carton label. The device has a unique set of reflective markers for surgical tracking. The expiration date on the patient label sticker should be 2027-04-01, not 2024-04-01.
Verify the expiration date on the patient label sticker matches 2027-04-01. If it shows 2024-04-01, this device is affected.
The contract manufacturer entered the manufacturing date (2024-04-01) as the expiration date instead of the actual expiration date (2027-04-01).
The device is safe to use if the expiration date on the patient label sticker shows 2027-04-01. If it shows 2024-04-01, it should not be used beyond the actual expiration date.
Check the patient label sticker for the expiration date. If it shows 2024-04-01, contact Trackx for guidance on safe handling.
We’ve drafted a message you can send Trackx to request your refund or repair — edit it as you like.
Subject: Recall Z-0260-2025 — Trackx Trackx Hello, I own a Trackx that is covered by recall Z-0260-2025 from Trackx. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
