COAPTIUM CONNECT nerve repair devices with model NCOCO6010 may break after 36 months due to unverified shelf life. Relabeled to 26 months; use beyond this risks revision surgery.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
COAPTIUM CONNECT nerve repair devices (model NCOCO6010) were recalled because their shelf life of 36 months isn't proven. Using them past this date could cause the device to break during surgery, requiring a revision procedure.
The device's shelf life of 36 months isn't supported by real-time data. If used beyond this period, it may break during surgery, requiring a revision procedure to fix the issue.
Patients who received the COAPTIUM CONNECT nerve repair device (model NCOCO6010) from 2020 to 2023 are likely affected. Medical professionals using these devices for nerve repairs are at higher risk.
Check for the model number NCOCO6010 on the device. Devices were sold between 2020 and 2023 with lot numbers 250700051, 251000044, or 251000045.
Look for the model number NCOCO6010 and lot numbers 250700051, 251000044, or 251000045 on the device.
The shelf life of 36 months isn't substantiated by real-time data. Using it beyond this period may cause the device to break during surgery.
Check the model number and lot numbers. If it's past the 26-month shelf life, contact the manufacturer for guidance.
The recall states that using the device beyond the validated shelf life could lead to revision surgery, but no immediate injury risk is mentioned.
We’ve drafted a message you can send COAPTIUM CONNECT to request your refund or repair — edit it as you like.
Subject: Recall Z-2908-2026 — COAPTIUM CONNECT COAPTIUM CONNECT Hello, I own a COAPTIUM CONNECT that is covered by recall Z-2908-2026 from COAPTIUM CONNECT. 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.
