Ionostar Plus and Ionolux
Brand(s)
Last updated
Summary
Product
Ionostar Plus and Ionolux
Issue
Medical devices - Labelling and packaging
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Ionostar Plus | More than 10 numbers, contact manufacturer. | 2547 2543 2544 2549 2545 2548 2546 |
| Ionolux | More than 10 numbers, contact manufacturer. | 2119 2118 2117 2120 2121 2124 2122 2123 |
| Ionolux | More than 10 numbers, contact manufacturer. | 2115 |
| Ionostar Plus | More than 10 numbers, contact manufacturer. | 2540 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Dental
Companies
Voco Gmbh
Anton-Flettner, Cuxhaven, Germany, 27472
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75003
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