In Situ Polymerizing Peripheral Nerve Repair Device
Neurology · 21 CFR 882.5270
An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries.
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
8 recall events for this product code
- TISSIUM SAOpen, ClassifiedAug 6, 2026
Brand Name: COAPTIUM Connect
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.
Z-2901-2026 · View FDA record ↗ - TISSIUM SAOpen, ClassifiedAug 6, 2026
Brand Name: COAPTIUM CONNECT
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.
Z-2902-2026 · View FDA record ↗ - TISSIUM SAOpen, ClassifiedAug 6, 2026
Brand Name: COAPTIUM CONNECT
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.
Z-2903-2026 · View FDA record ↗ - TISSIUM SAOpen, ClassifiedAug 6, 2026
Brand Name: COAPTIUM CONNECT
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.
Z-2904-2026 · View FDA record ↗ - TISSIUM SAOpen, ClassifiedAug 6, 2026
Brand Name: COAPTIUM CONNECT
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.
Z-2905-2026 · View FDA record ↗ - TISSIUM SAOpen, ClassifiedAug 6, 2026
Brand Name: COAPTIUM CONNECT
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.
Z-2906-2026 · View FDA record ↗ - TISSIUM SAOpen, ClassifiedAug 6, 2026
Brand Name: COAPTIUM CONNECT
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.
Z-2907-2026 · View FDA record ↗ - TISSIUM SAOpen, ClassifiedAug 6, 2026
Brand Name: COAPTIUM CONNECT
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.
Z-2908-2026 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
510(k) clearances
2 clearances for this product code