COAPTIUM CONNECT nerve repair devices recalled for potential failure after 36 months due to unverified shelf life. Relabeled to 26 months. Contact for replacement.
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 are being recalled because their shelf life of 36 months isn't proven by real data. Using them beyond 26 months could cause the device to break during surgery, requiring a revision operation.
The device's shelf life was originally labeled as 36 months but isn't backed by real-world data. If used beyond 26 months, it might break during surgery, leading to a revision procedure.
Patients who received COAPTIUM CONNECT nerve repair devices with model NCOCO5010 and lot numbers 250700050, 251000043, 260300048, 260300049, or 260300050 are affected. Surgeons using these devices for nerve repairs are at risk.
Check for model number NCOCO5010 and lot numbers 250700050, 251000043, 260300048, 260300049, or 260300050 on the device packaging.
Look for model number NCOCO5010 and lot numbers 250700050, 251000043, 260300048, 260300049, or 260300050 on the device packaging.
The original 36-month shelf life wasn't verified with real-time data. Devices are now relabeled to a 26-month shelf life.
The worst-case outcome is that the device may need revision surgery.
No, but if the device is older than 26 months, it should be checked with the manufacturer.
We’ve drafted a message you can send COAPTIUM CONNECT to request your refund or repair — edit it as you like.
Subject: Recall Z-2907-2026 — COAPTIUM CONNECT COAPTIUM CONNECT Hello, I own a COAPTIUM CONNECT that is covered by recall Z-2907-2026 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.
