TISSIUM SA: Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: I
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- TISSIUM SA
- Product
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
- Recall initiated
- 2026-06-15
- Code info
- Lot Code: Model No NCOCO3010; UDI-DI 03760279380117; Lot Numbers 250700045, 251000040, 251000036, 251000037, 251000039, 251000035, and 251000064
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Paris 12e Arrondissement
- Country
- France
- Event id
- 99345
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