Z-2904-2026Class II

Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version...

Name: Z-2904-2026 Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version...
Creator: Tissium Sa
Published: 2026-06-15
License: https://open.fda.gov/license/

Tissium SA / initiated 2026-06-15 / Open, Classified / root cause: labeling and UDI

FDA source

TISSIUM SA began a recall of Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: In situ polymerizing... on 2026-06-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2904-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-15
Posted: 2026-08-06
Recalling firm: Tissium SA
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
Product code: SFD In Situ Polymerizing Peripheral Nerve Repair Device
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.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: On 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.
Distribution: US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
Product codes and lots: Lot Code: Model No NCOCO2075; UDI-DI ¿03760279380100; Lot Number 250700016, 251000048, 251000049, and 260300043

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2904-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2901-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-06
Z-2902-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-06
Z-2903-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-06
Z-2904-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-06
Z-2905-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-06
Z-2906-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-06
Z-2907-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-06
Z-2908-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-06

Product code SFD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)