Tissium Coaptium Connect device recalled for unverified shelf life
The labeled 36-month shelf life for the COAPTIUM CONNECT nerve repair device is not supported by real-time data. The devices will be relabeled with a revised 26-month shelf life. Using a device past its validated shelf life may cause it to break during surgery, making it unusable; the worst-case outcome would be revision surgery. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Do not use COAPTIUM CONNECT devices beyond the revised 26-month shelf life.
- Check affected devices: Model NCOCO4010, UDI-DI 03760279380148, lot numbers 251000041, 250700048, 260300046, 260400050, and 260300047.
- The notice does not specify a remedy beyond relabeling; contact Tissium SA about the relabeled devices.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 7 products — see all of them.
Details
- Illnesses reported
- None reported
- Manufactured in
- 74 Rue Du Faubourg Saint-Antoine, Paris 12e Arrondissement, France
- Classification
- Class II
- Recall number
- Z-2906-2026
In the FDA's words
- Description
- 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 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. Lot Code: Model No NCOCO4010; UDI-DI 03760279380148; Lot Numbers 251000041, 250700048, 260300046, 260400050, and 260300047 Distribution: US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
- 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.
7 products in this recall
The agency lists each product separately. Check every one you might have.
- Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizi…Z-2901-2026
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizi…Z-2902-2026
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizi…Z-2903-2026
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: In situ polymerizi…Z-2904-2026
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizi… (this page)Z-2906-2026
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizi…Z-2907-2026
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizi…Z-2908-2026