TemporaryFDAOngoing
Can cause harm that is usually temporary.
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Check the device or its packaging for
Lot Code: Model No NCOCO5010; UDI-DI 03760279380179; Lot Numbers 250700050, 251000043, 260300048, 260300049, and 260300050
- Why
- 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.
- Distributed
- US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
- Company
- TISSIUM SA
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2907-2026 · retrieved 6 August 2026
Read the official notice