Reported Feb 28, 2024 · Ongoing
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
Voco GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Voco GmbH · Anton-Flettner-Str. 1-3 · Cuxhaven, N/A · N/A
Is this the product you have?
- IonoStar Plus
- Catalog (REF) Numbers
a) 2540b)2543c) 2544d) 2545e) 2546f) 2547g) 2549dental cement
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 2338699, 2347154 2 2543, UDI/DI +E22125431, Lot Numbers: 2344046 3 2544, UDI/DI +E22125441, Lot Numbers: 2342759, 2439537 4 2545, UDI/DI +E22125451, Lot Numbers: 2348503 5 2546, UDI/DI +E22125461, Lot Numbers: 2344045, 2349452 6 2547, UDI/DI +E22125471, Lot Numbers: 2349453 7 2549, UDI/DI +E22125491, Lot Numbers: 2342760, 2344016, 2344047, 2351233 - Amount recalled
- 1530 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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 Ionolux. When these capsules are activated, curing is significantly delayed and incomplete. Processing according to the instructions for use is not possible.
This product could cause temporary or reversible health problems — stop using it.
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