FDAFDA · Food and drugs·Recall number Z-2906-2026
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
Published August 12, 2026 · Recall initiated: June 15, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- TISSIUM SA
- Distributor
- US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
- Lot
- Lot Code: Model No NCOCO4010; UDI-DI 03760279380148; Lot Numbers 251000041, 250700048, 260300046, 260400050, and 260300047
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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