Recall Z-2902-2026— TISSIUM SA
Class II · Ongoing
Class II FDA medical device recall by TISSIUM SA, initiated 2026-06-15. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..
- Recalling firm
- TISSIUM SA
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-15
- Firm location
- Paris 12e Arrondissement, France
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.