Tissium Peripheral Nerve Repair Device Shelf Life Recall
Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device due to an unsubstantiated 36-month shelf life; devices will be relabeled to a validated 26-month shelf life.
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: This is an FDA Class II recall where the hazard is a risk-of-harm product (device breakage beyond validated shelf life) with no reported illness or injury, which aligns with the High severity criteria 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 No. NCOCO2010) because the currently labeled shelf life of 36 months is not supported by real-time data. The device will be relabeled to reflect a revised, validated shelf life of 26 months.
The recall affects devices distributed nationwide in the states of CA, FL, IL, NJ, OH, and PA. The affected units are identified by lot numbers 250700042, 251000033, and 251000034, and UDI-DI 03760279380094.
Using the device beyond its validated shelf life may result in perioperative breakage, rendering the device unusable. The worst-case outcome is revision surgery.
Healthcare facilities should contact Tissium SA regarding the relabeling of affected devices. Consumers or patients with questions should consult their healthcare provider.
The recalled product
- Product
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 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 NCOCO2010
- UDI-DI 03760279380094
- Lot Number 250700042
- 251000033
- and 251000034
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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