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U.S. Department of Health and Human Services

Class 2 Device Recall COAPTIUM CONNECT

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 Class 2 Device Recall COAPTIUM CONNECTsee related information
Date Initiated by FirmJune 15, 2026
Date PostedAugust 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2902-2026
Recall Event ID 99345
Product Classification In Situ Polymerizing Peripheral Nerve Repair Device - Product Code SFD
ProductBrand 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
Code Information Lot Code: Model No NCOCO1575; UDI-DI ¿03760279380087; Lot Number 250700007, 251000031, and 260300041
FEI Number 3021453307
Recalling Firm/
Manufacturer		 TISSIUM SA
74 Rue Du Faubourg Saint-Antoine
Paris 12e Arrondissement France
For Additional Information ContactHallie ARLOTTA
1-317-9957384
Manufacturer 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.
FDA Determined
Cause 2		Incorrect or no expiration date
ActionOn June 25, 2026, the firm began notifying consignees via direct visit by medical representatives to deliver the Customer Recall Notification Letter in person. Representatives removed affected units from customer shelves, collected completed response forms, and provided conforming replacement product on the same day.
DistributionUS Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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