COAPTIUM CONNECT devices with model NCOCO3010 may have unverified 36-month shelf life. Relabeled 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 medical devices with model number NCOCO3010 were recalled because their original 36-month shelf life isn't proven. Using them beyond 26 months could cause breakage during surgery, requiring additional procedures.
The device's shelf life was originally labeled as 36 months but lacks real-time validation. If used beyond 26 months, it may break during surgery, requiring revision surgery.
Patients receiving COAPTIUM CONNECT nerve repair devices with model NCOCO3010 are affected. Surgeons and medical facilities using these devices are most at risk.
Check for model number NCOCO3010 on the device. Devices with lot numbers 250700045, 251000040, 251000036, 251000037, 251000039, 251000035, or 251000064 are affected.
Look for model number NCOCO3010 and affected lot numbers on the device.
The original 36-month shelf life wasn't verified by real-time data. Devices may break during surgery if used beyond 26 months.
The device will be relabeled to show a 26-month shelf life instead of the previously labeled 36 months.
Check the device label for model number NCOCO3010 and affected lot numbers. No action is needed if the device is within the 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-2905-2026 — COAPTIUM CONNECT COAPTIUM CONNECT Hello, I own a COAPTIUM CONNECT that is covered by recall Z-2905-2026 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.
