Recall Z-2907-2026
Tissium SA · initiated June 15, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Codes / lots: Lot Code: Model No NCOCO5010; UDI-DI 03760279380179; Lot Numbers 250700050, 251000043, 260300048, 260300049, and 260300050
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: Incorrect or no expiration date
Action taken
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.
Details
- Recall number
- Z-2907-2026
- Initiated
- June 15, 2026
- Posted by FDA
- August 6, 2026
- Product code
- SFD – In Situ Polymerizing Peripheral Nerve Repair Device
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
- Recalling firm
- Tissium SA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2901-2026 Class II | Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |
| Z-2902-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |
| Z-2903-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |
| Z-2904-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |
| Z-2905-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |
| Z-2906-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |
| Z-2908-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | 06/15/2026Open, Classified |