Heraeus, PALAMIX duo. Material Number: 66057897.
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Low |
| Status | ongoing |
| Recall date | March 25, 2026 |
| Reported | May 06, 2026 |
| Recalling firm | Heraeus Medical GmbH (Dental Division) |
| Country / region | Germany 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.; |
Hazard
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).
Affected products
- Heraeus, PALAMIX duo. Material Number: 66057897.
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