FDA Medical Device Recalls (openFDA)
TISSIUM SA: 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
- Recall number
- Z-2905-2026
- Recalling firm
- TISSIUM SA
- Product
- 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
- Status
- Open, Classified
- Initiated
- 2026-06-15
- Posted
- 2026-08-06
- Terminated
- not on file
- 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. 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
- 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.
- Quantity
- not on file
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
- Lot, serial or model codes
- Lot Code: Model No NCOCO3010; UDI-DI 03760279380117; Lot Numbers 250700045, 251000040, 251000036, 251000037, 251000039, 251000035, and 251000064
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- SFD
- Firm FEI
- 3021453307
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28