Tissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall
Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device because the labeled 36-month shelf life is not supported by real-time data; the validated shelf life is 26 months.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall where the hazard is a risk-of-harm product (device breakage leading to revision surgery) without reported illness or injury, which corresponds to the High severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Tissium SA is recalling the COAPTIUM CONNECT in situ polymerizing peripheral nerve repair device, model NCOCO2075. The recall covers lot numbers 250700016, 251000048, 251000049, and 260300043, distributed nationwide in the states of CA, FL, IL, NJ, OH, and PA.
The reason for the recall is that the currently labeled shelf life of 36 months is not substantiated by real-time data. The devices will be relabeled to reflect a revised shelf life of 26 months.
The hazard is that using the device beyond its validated shelf life may result in perioperative breakage of the device, rendering it unusable. The worst-case outcome would be the need for revision surgery.
Healthcare facilities and users should contact Tissium SA regarding the shelf life correction and device relabeling. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 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 (6)
- Lot Code: Model No NCOCO2075
- UDI-DI ¿03760279380100
- Lot Number 250700016
- 251000048
- 251000049
- and 260300043
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 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
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
Same hazard · device breakage
See all →- HighPeripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighTissium Peripheral Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
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