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TISSIUM SA recalls Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Pr
Recalled August 12, 2026 · FDA recall Z-2904-2026 · TISSIUM SA
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. · FDA Class II
Sold at
US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
Description
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.
Product
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
Manufacturer(s)
TISSIUM SA
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →