⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

TISSIUM SA: Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: I

Medical DevicesSource: FDA (device) · Date: 2026-08-12

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
TISSIUM SA
Product
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
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
Recall initiated
2026-06-15
Code info
Lot Code: Model No NCOCO6010; UDI-DI ¿03760279380209; Lot Numbers 250700051, 251000044, and 251000045
Voluntary mandated
Voluntary: Firm initiated
City
Paris 12e Arrondissement
Country
France
Event id
99345
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