Coaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling Coaptium Connect nerve repair devices because the current 36-month shelf life is not supported by real-time data. The shelf life is being reduced to 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 recall is classified as FDA Class II and 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 NCOCO5010) because the current 36-month shelf life is not substantiated by real-time data. The devices will be relabeled to reflect a revised shelf life of 26 months.
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 with Model No NCOCO5010 and UDI-DI 03760279380179, specifically lot numbers 250700050, 251000043, 260300048, 260300049, and 260300050. Distribution is limited to CA, FL, IL, NJ, OH, and PA.
The recalled product
- Product
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 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 (7)
- Lot Code: Model No NCOCO5010
- UDI-DI 03760279380179
- Lot Numbers 250700050
- 251000043
- 260300048
- 260300049
- and 260300050
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 →- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
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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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