FDA Medical devices recall ·
COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model recall
- Recall number
- Z-2905-2026
- Date
- (initiated June 15, 2026)
- Company / brand
- Tissium Sa
74 Rue Du Faubourg Saint-Antoine, Paris 12e Arrondissement, France - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Why was it recalled?
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Model No NCOCO3010; UDI-DI 03760279380117; Lot Numbers 250700045, 251000040, 251000036, 251000037, 251000039, 251000035, and 251000064
Distribution
US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
States: California Florida Illinois New Jersey Ohio Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2905-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.