FDAFDA · Alimentos y medicamentos·N.º oficial Z-1998-2026
Heraeus, PALAMIX duo. Material Number: 66057897.
Publicado el 6 de mayo de 2026 · Inicio del retiro: 25 de marzo de 2026
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
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Heraeus Medical GmbH (Dental Division)
- Distribuidor
- Worldwide distribution - US Nationwide and the countries of Aland Islands, Algeria, Australia, Austria, Belgium, Brazil , Chile, China, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Kosovo, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Rep. of Korea, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, Uruguay, Utd.Arab Emir.;
- Lote
- Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;
- Clasificación de riesgo
- Class III
- Área (FDA)
- device
- País
- Germany
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