Peripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling COAPTIUM CONNECT nerve repair devices because the 36-month shelf life is not supported by real-time data. The revised shelf life is 26 months.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The hazard involves a risk of device breakage requiring revision surgery, which constitutes a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Tissium SA is relabeling the COAPTIUM CONNECT in situ polymerizing peripheral nerve repair device (Model No NCOCO1575) to reflect a revised shelf life of 26 months. The previous 36-month shelf life was not substantiated by real-time data.
Using the device beyond its validated shelf life may result in perioperative breakage, which would render the device unusable. The worst-case outcome of such breakage is the need for revision surgery.
This recall affects devices distributed nationwide in California, Florida, Illinois, New Jersey, Ohio, and Pennsylvania. Affected lot numbers include 250700007, 251000031, and 260300041.
The recalled product
- Product
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
- Manufacturer
- TISSIUM SA
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot Code: Model No NCOCO1575
- UDI-DI ¿03760279380087
- Lot Number 250700007
- 251000031
- and 260300041
Distribution
Part of a larger recall action
This product is one of 8 recalled by TISSIUM SA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · TISSIUM SA
See all →- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCoaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
- ModerateCOAPTIUM CONNECT peripheral nerve repair device recalled due to inaccurate shelf life labeling
FDA (Devices) · 2026-08-12
- ModerateCOAPTIUM CONNECT medical device shelf life recalibration recall
FDA (Devices) · 2026-08-12
Same hazard · device breakage
See all →- HighTissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighTissium Peripheral Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighZimmer Off-Axis Comprehensive Shoulder System Reamer Guide Recall
FDA (Devices) · 2026-07-01
- HighSurgify Halo Surgical Burr Recalled for Breakage Risk
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical drill equipment recalled for potential burr breakage
FDA (Devices) · 2026-07-01