FDA DevicesClass III
Heraeus, PALAMIX uno. Material Number: 66057893.
Published: May 6, 2026Recall ID: Z-1997-2026Category: devicesCountry: US
Reason for Recall / 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).
Product Description & Identification
Heraeus, PALAMIX uno. Material Number: 66057893.
Additional Source Details
| Field | Value |
|---|---|
| City | Wehrheim |
| Event id | 98608 |
| Address 1 | Philipp-Reis-Str. 8 |
| Code info | Material Number: 66057893; UDI-DI: 04260102133587; Batch: all batches with numbers below 223060; |
| Postal code | N/A |
| Report date | 20260506 |
| Product type | Devices |
| Product quantity | 51,771 units |
| Reason for recall | 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). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260325 |
| Initial firm notification | Letter |
| Center classification date | 20260429 |
Overview
- Recalling FirmHeraeus Medical GmbH (Dental Division)
- StatusOngoing
- Risk LevelClass III
- DistributionWorldwide 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.;