Health product recall

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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