Ionolux, Catalog (REF) Numbers: a) 2115, b)2117, c) 2118, d) 2119, e) 2120, f) 2122; dental cement
This recall is currently active, issued February 16, 2024. It was issued by Voco Gmbh Anton-Flettner-Str. 1-3 Cuxhaven Germany.
- Recall Initiated
- January 25, 2024
- Posted
- February 16, 2024
- Recall Number
- Z-1143-2024
- Quantity
- 1021 units
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide distribution: US distribution to states of: IA, NY, PA, WA; and OUS (foreign) to countries of: Belgium, Bulgaria, Denmark, Germany, France, Greece, Great Britain, India, Italy, Canada, Quatar, Lithuania, Netherlands, Northern Ireland, Norway, Poland, Portugal, Romania, Sweden, Switzerland, Slovakia, Spain, Czech Republic, Australia, Saudi Arabia, & Ireland.
Lot / Code Info
a) 2115, UDI/DI +E22121151, Lot Numbers: 2346779, 2401515; b) 2117, UDI/DI +E22121171, Lot Numbers: 2347832; c) 2118, UDI/DI +E22121181, Lot Numbers: 2349536; d) 2119, UDI/DI +E22121191, Lot Numbers: 2348501; e) 2120, UDI/DI +E22121201, Lot Numbers: 2350638; f) 2122, UDI/DI +E22121221, Lot Numbers: 2349527
Root Cause
Process control
Action Taken
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.