Official recall notice
FDA DeviceClass IIINotable
FDA Recall: Heraeus, PALAMIX duo. Material Number: 66057897.
- Recall date
- 2026-05-06
- Category
- Medical Device
- FDA class
- Class III
Why it was recalled
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).
Recommended action
What to do
1,125 units
Product description
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).