COAPTIUM CONNECT nerve repair devices recalled due to unverified 36-month shelf life; revised to 26 months to prevent perioperative breakage requiring 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 with model NCOCO4010 have a recalled shelf life of 26 months instead of 36 months. Using them beyond this period risks perioperative breakage that could require revision surgery.
The device's shelf life was not properly verified through real-time data. If used beyond 26 months, it may break during surgery, requiring additional surgery to fix the issue.
Patients who received COAPTIUM CONNECT nerve repair devices with model NCOCO4010 are affected. Surgeons and medical staff using these devices during procedures are at higher risk.
Check for model number NCOCO4010 on the device. Devices sold with lot numbers 251000041, 250700048, 260300046, 260400050, or 260300047 are affected.
Verify the device's current shelf life label; affected devices should have a revised shelf life of 26 months instead of 36 months.
The manufacturer found the original 36-month shelf life wasn't properly verified through real-time data, so it was revised to 26 months.
The device may need revision surgery to fix the issue, but this is a worst-case scenario.
Check the device's model number and lot numbers to see if it's affected; no action is needed if it's within the revised 26-month shelf life.
We’ve drafted a message you can send COAPTIUM CONNECT to request your refund or repair — edit it as you like.
Subject: Recall Z-2906-2026 — COAPTIUM CONNECT COAPTIUM CONNECT Hello, I own a COAPTIUM CONNECT that is covered by recall Z-2906-2026 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.
