TemporaryFDAOngoing
Can make you unwell for a while. Do not eat it.
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Check your package for
Lot Code: Model No NCOCO6010; UDI-DI ¿03760279380209; Lot Numbers 250700051, 251000044, and 251000045
- 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
- Recall began