FDAFDA · Alimentos y medicamentos·N.º oficial Z-1142-2024
IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement
Publicado el 28 de febrero de 2024 · Inicio del retiro: 25 de enero de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Voco GmbH
- Distribuidor
- 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.
- Lote
- 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
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Germany
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