Tissium Sa: In Situ Polymerizing Peripheral Nerve Repair Device
COAPTIUM Connect Recall Summary TISSIUM SA is recalling COAPTIUM Connect, a device used to repair peripheral nerves, because the labeled shelf life of 36 months is not supported by actual data. The shelf life is being reduced to 26 months, and devices will be relabeled accordingly. If used beyond its validated shelf life, the device may break during surgery and become unusable, potentially requiring additional surgery to repair.
- Recalling firm
- TISSIUM SA
- Product
- 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
- 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/8261b36d-3b2e-4ff2-9397-5d8ff9a317a3