TISSIUM SA recalls Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT
- Recalling company
- TISSIUM SA
- Product
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 15, 2026
- Reported
- Aug 12, 2026
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
- Status
- Ongoing
- Lot / codes
- Lot Code: Model No NCOCO4010; UDI-DI 03760279380148; Lot Numbers 251000041, 250700048, 260300046, 260400050, and 260300047
- Company location
- Paris 12e Arrondissement
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2906-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2906-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.