COAPTIUM CONNECT medical device shelf life recalibration recall
TISSIUM SA is recalling COAPTIUM CONNECT devices because their original 36-month shelf life was not supported by real-time data, requiring relabeling to a 26-month shelf life to prevent potential device failure during surgery.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall involves a medical device with a corrected shelf-life error that could lead to device failure during surgery, but no injuries or illnesses have been reported. Per the rubric, this fits the 'moderate' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration is issuing recall Z-2908-2026 for the COAPTIUM CONNECT, a medical device used for in situ polymerizing peripheral nerve repair. The recall stems from the fact that the originally labeled 36-month shelf life was not substantiated by real-time monitoring data. As a result, the devices will be relabeled to reflect a revised shelf life of 26 months. The agency warns that using a medical device beyond its validated shelf life may cause perioperative breakage, rendering the device unusable and potentially requiring revision surgery. Consumers are advised to stop using the affected units and follow the updated labeling instructions. The recall affects nationwide distribution across multiple states including California, Florida, Illinois, New Jersey, Ohio, and Pennsylvania.
This recall focuses on correcting inaccurate shelf-life information rather than addressing direct patient harm. No illnesses or injuries have been reported in connection with this recall, and the agency classifies the device as a Class II medical device. The primary hazard is the risk of device failure during surgical procedures when operated outside the validated shelf life period. By updating the shelf-life information, the manufacturer aims to ensure patient safety and maintain device functionality.
Consumers should discontinue use of any COAPTIUM CONNECT units associated with lot numbers 250700051, 251000044, and 251000045. They should consult the updated labeling reflecting the 26-month shelf life and seek replacement or proper disposal through the manufacturer's process. The recall does not involve any fatalities or serious injuries, and no additional risks beyond the potential for device malfunction are currently documented.
The recalled product
- Product
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
- Manufacturer
- TISSIUM SA
- Category
- Medical Device
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 NCOCO6010
- UDI-DI ¿03760279380209
- Lot Numbers 250700051
- 251000044
- and 251000045
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
- HighPeripheral 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