COAPTIUM CONNECT nerve repair devices may need revision surgery if used beyond 26 months shelf life. Recalled model NCOCO2075 has unverified 36-month label; updated to 26 months.
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 NCOCO2075 have an unverified 36-month shelf life. Using them beyond 26 months could cause device breakage requiring revision surgery.
The device may break during surgery if used beyond its validated shelf life, causing the need for additional surgery. The current 36-month label isn't supported by real-time data, so the actual shelf life is shorter.
Patients who received COAPTIUM CONNECT nerve repair devices with model NCOCO2075 are affected. Those using devices beyond 26 months of shelf life face revision surgery risk.
Check for model number NCOCO2075 on the device. Devices sold with lot codes 250700016, 251000048, 251000049, or 260300043 are affected.
Verify the device's current shelf life by checking the label or documentation.
The manufacturer found the original 36-month shelf life wasn't supported by real-time data, so they updated it to 26 months.
The device may break during surgery, requiring revision surgery.
Check for model number NCOCO2075 and lot codes 250700016, 251000048, 251000049, or 260300043.
We’ve drafted a message you can send COAPTIUM CONNECT to request your refund or repair — edit it as you like.
Subject: Recall Z-2904-2026 — COAPTIUM CONNECT COAPTIUM CONNECT Hello, I own a COAPTIUM CONNECT that is covered by recall Z-2904-2026 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.
