Heraeus Medical GmbH (Dental Division) — Heraeus, PALAMIX duo. Material Number: 66057897.
⚠️ 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).
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 25, 2026
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.;
What's affected?
- Product
- Heraeus, PALAMIX duo. Material Number: 66057897.
- Lot code
- Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;
Additional details
Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 1,125 units.
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