FDA recall, , Moderate risk
TISSIUM COAPTIUM Connect Peripheral Nerve Repair Devices
Currently labeled shelf life of 36 months is not substantiated by real-time data.
Summary by Recall Canary from the FDA notice
What happened
TISSIUM SA, based in Paris 12e Arrondissement, France, is recalling its Coaptium Connect in situ polymerizing peripheral nerve repair device because the currently labeled shelf life of 36 months is not substantiated by real-time data. The company began the recall on June 15, 2026, and the FDA added it to the Enforcement Report on August 6, 2026.
Use of the device beyond its validated shelf life may result in perioperative breakage, rendering the device unusable, with the worst-case outcome being revision surgery. The recall affects distribution in California, Florida, Illinois, New Jersey, Ohio, and Pennsylvania.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match your product and all the details in one listed combination.
A UDI-DI is the device identifier printed with the barcode on the device label.
COAPTIUM Connect
- UDI-DI
- 03760279380094
- 250700042
- 251000033
- 251000034
- Model/Catalog number
- NCOCO2010
- UDI-DI
- 03760279380148
- 251000041
- 250700048
- 260300046
- 260400050
- 260300047
- Model/Catalog number
- NCOCO4010
- UDI-DI
- 03760279380179
- 250700050
- 251000043
- 260300048
- 260300049
- 260300050
- Model/Catalog number
- NCOCO5010
- UDI-DI
- 03760279380100
- 250700016
- 251000048
- 251000049
- 260300043
- Model/Catalog number
- NCOCO2075
- UDI-DI
- 03760279380070
- 250700041
- 251000032
- Model/Catalog number
- NCOCO1510
- UDI-DI
- 03760279380087
- 250700007
- 251000031
- 260300041
- Model/Catalog number
- NCOCO1575
- UDI-DI
- 03760279380209
- 250700051
- 251000044
- 251000045
- Model/Catalog number
- NCOCO6010
- UDI-DI
- 03760279380117
- 250700045
- 251000040
- 251000036
- 251000037
- 251000039
- 251000035
- 251000064
- Model/Catalog number
- NCOCO3010
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, Florida, Illinois, New Jersey, Ohio, Pennsylvania.
- Company
- TISSIUM SAParis 12e Arrondissement, France
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99345
- Recall numbers
- Z-2901-2026 to Z-2908-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
