Recall Z-2901-2026 ยท SFD In Situ Polymerizing Peripheral Nerve Repair Device
TISSIUM SA
Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A
| Date | Aug 6, 2026 (initiated Jun 15, 2026) |
| Status | Open, Classified |
| 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. |
| Distribution | US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.