Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Pr
Summary
The FDA issued a Class II for Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Numb by TISSIUM SA. 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.
Details
Source
Device Recall
External ID
Z-2905-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: Model No NCOCO3010; UDI-DI 03760279380117; Lot Numbers 250700045, 251000040, 251000036, 251000037, 251000039, 251000035, and 251000064
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.
Distribution
US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-15
Company
Paris 12e Arrondissement
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
TISSIUM SA has 10 FDA actions in our database, including 8 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TISSIUM SA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TISSIUM SA have FDA actions?
TISSIUM SA has 10 FDA actions in our database, including 8 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2905-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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