Product Wiki · Recalls · Health Canada — Medical Devices

Ionostar Plus and Ionolux — recall 75003

Health Canada — Medical Devices · Canada · 2024-02-02 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
75003
Date of alert
2024-02-02
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Dental
Product type
Medical devices
Reported risk: Due to an error in the manufacturing process, it is possible that an incorrect plunger has been fitted to some capsules. This plunger does not contain the correct reactive component for Ionostar Plus. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the Instructions For Use (IFU) is not possible. The reactive component in the incorrect plungers contains small amounts of BHT and Methacrylate. These ingredients are not listed in the IFU. Recall Start Date: January 23, 2024
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ionostar-plus-and-ionolux

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