IonoStar Plus (Voco) – Plunger Fitting Error (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
Brand
Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany
Lot Codes / Batch Numbers
a) 2540, UDI/DI +E22125401, Lot Numbers: 2338699, 2347154, b)2543, UDI/DI +E22125431, Lot Numbers: 2344046, c) 2544, UDI/DI +E22125441, Lot Numbers: 2342759, 2439537, d) 2545, UDI/DI +E22125451, Lot Numbers: 2348503, e) 2546, UDI/DI +E22125461, Lot Numbers: 2344045, 2349452, f) 2547, UDI/DI +E22125471, Lot Numbers: 2349453, g) 2549, UDI/DI +E22125491, Lot Numbers: 2342760, 2344016, 2344047, 2351233
Products Sold
a) 2540, UDI/DI +E22125401, Lot Numbers: 2338699, 2347154; b)2543, UDI/DI +E22125431, Lot Numbers: 2344046; c) 2544, UDI/DI +E22125441, Lot Numbers: 2342759, 2439537; d) 2545, UDI/DI +E22125451, Lot Numbers: 2348503; e) 2546, UDI/DI +E22125461, Lot Numbers: 2344045, 2349452; f) 2547, UDI/DI +E22125471, Lot Numbers: 2349453; g) 2549, UDI/DI +E22125491, Lot Numbers: 2342760, 2344016, 2344047, 2351233
Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany is recalling IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Voco issued a field safety notice to its consignees on 01/25/2024 via email. The notice explained the problem, risk, and requested the product be returned. Those who have sold the product were directed to notify their customers and collect the affected product. For questions contact Mr. Michael Cyll at m.cyll@voco.de.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IA, NY, PA, WA
Page updated: Jan 10, 2026