Heraeus Medical GmbH (Dental Division) recalls Heraeus, PALAMIX duo. Material Number: 66057897.
See all recalls from Heraeus Medical GmbH (Dental Division) →Recalled Product
Heraeus, PALAMIX duo. Material Number: 66057897.
Hazard / Issue
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).
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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