Tissium Sa: In Situ Polymerizing Peripheral Nerve Repair Device
- 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
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-15
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f48aaf20-0d8a-4c41-a6d6-95a1f3d81da6