COAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling COAPTIUM Connect nerve repair devices to reduce the shelf life from 36 to 26 months because the original duration was not supported by real-time data.
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 recall is classified as FDA Class II and involves a risk of harm (potential for revision surgery) for a high-risk medical device, though no injuries have been reported.
Plain-English summary
Tissium SA is relabeling the COAPTIUM Connect in situ polymerizing peripheral nerve repair device (Model/Catalog Number NCOCO1510) to reflect a revised shelf life of 26 months. The previous 36-month shelf life was not substantiated by real-time data.
This recall affects devices with Lot Numbers 250700041 and 251000032, distributed nationwide in California, Florida, Illinois, New Jersey, Ohio, and Pennsylvania.
Using the device beyond its validated shelf life may cause the device to break during surgery, which could require revision surgery to correct.
The recalled product
- 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
- 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 (3)
- Lot Code: Model No NCOCO1510
- UDI-DI 03760279380070
- Lot Numbers 250700041 and 251000032
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
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See all →- HighPeripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
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- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
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- 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
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