United StatesCOAPTIUM Connect in situ polymerizing peripheral nerve repair devices — models NCOCO1510, NCOCO1575, NCOCO2010, NCOCO2075, NCOCO3010, NCOCO4010, NCOCO5010 and NCOCO6010, with the specific lot numbers listed in the FDA notice — are included in the recall. The labeled 36‑month shelf life is not substantiated by real‑time data; devices will be relabeled to a revised 26‑month shelf life because use beyond the validated shelf life may cause perioperative breakage rendering the device unusable and could require revision surgery.
What's being recalled
Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
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
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
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
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
Recalling firm: Tissium Sa, Paris 12e Arrondissement, France.
How to identify it
Lot Code: Model No NCOCO1510; UDI-DI 03760279380070; Lot Numbers 250700041 and 251000032 Lot Code: Model No NCOCO1575; UDI-DI ¿03760279380087; Lot Number 250700007, 251000031, and 260300041 Lot Code: Model No NCOCO2010; UDI-DI 03760279380094; Lot Number 250700042, 251000033, and 251000034 Lot Code: Model No NCOCO2075; UDI-DI ¿03760279380100; Lot Number 250700016, 251000048, 251000049, and 260300043 Lot Code: Model No NCOCO3010; UDI-DI 03760279380117; Lot Numbers 250700045, 251000040, 251000036, 251000037, 251000039, 251000035, and 251000064 Lot Code: Model No NCOCO4010; UDI-DI 03760279380148; Lot Numbers 251000041, 250700048, 260300046, 260400050, and 260300047 Lot Code: Model No NCOCO5010; UDI-DI 03760279380179; Lot Numbers 250700050, 251000043, 260300048, 260300049, and 260300050 Lot Code: Model No NCOCO6010; UDI-DI ¿03760279380209; Lot Numbers 250700051, 251000044, and 251000045
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)