COAPTIUM CONNECT devices with model NCOCO2010 may become unusable after 26 months due to shelf life issues. Affected units require attention to avoid revision surgery risks.
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 NCOCO2010 have a recalled shelf life of 26 months instead of the previously labeled 36 months. Using these devices beyond the revised shelf life could cause them to break during surgery, requiring additional procedures.
The device may break during surgery if used beyond its validated shelf life of 26 months. This could lead to the need for revision surgery as a worst-case outcome. The risk is tied to the device's shelf life and not to normal use conditions.
Patients using COAPTIUM CONNECT peripheral nerve repair devices with model NCOCO2010 are affected. Those who have the device within the specified lot numbers and are scheduled for surgery are most at risk.
Check for model number NCOCO2010 on the device. Look for lot numbers 250700042, 251000033, or 251000034. The device is an in situ polymerizing peripheral nerve repair device.
Verify the model number and lot numbers on your device to confirm if it is affected by this recall.
The manufacturer found that the previously labeled 36-month shelf life wasn't supported by real-time data. They revised it to 26 months based on validation.
The device may break during surgery, potentially requiring revision surgery as a worst-case outcome.
Check the model number and lot numbers to see if your device is affected. If so, contact the manufacturer for further instructions.
We’ve drafted a message you can send COAPTIUM CONNECT to request your refund or repair — edit it as you like.
Subject: Recall Z-2903-2026 — COAPTIUM CONNECT COAPTIUM CONNECT Hello, I own a COAPTIUM CONNECT that is covered by recall Z-2903-2026 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.
