Z-1142-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2024
- Initiation Date
- January 25, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1530 units
Product Description
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
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 Pattern
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.
Code Information
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