Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
USBrand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Recalling Firm: TISSIUM SA
Reason for Recall / Hazard
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.
Product Description & Identification
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Affected Products
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Additional Source Details
| Field | Value |
|---|---|
| City | Paris 12e Arrondissement |
| Event id | 99345 |
| Address 1 | 74 Rue Du Faubourg Saint-Antoine |
| Code info | Lot Code: Model No NCOCO2010; UDI-DI 03760279380094; Lot Number 250700042, 251000033, and 251000034 |
| Postal code | N/A |
| Report date | 20260812 |
| Product type | Devices |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260615 |
| Initial firm notification | Letter |
| Center classification date | 20260806 |
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Overview
- Recalling FirmTISSIUM SA
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
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🚨 SAFETY ALERT: TISSIUM SA - Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No Check if your household is affected: https://therecallfile.com/recalls/brand-name-coaptium-connect-product-name-coaptium-connect-model-catalo/FDA-Z-2903-2026
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