Heraeus PALAMIX uno Dental Material Mixing Rod Loose Risk Recall
Heraeus Medical is recalling PALAMIX uno dental material because the mixing rod may come loose during mixing in units older than 1.5 years. The shelf life has been reduced from 3 years to 1.5 years.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is a theoretical risk (mixing rod may come loose in rare cases), no injuries or illnesses have been reported, and the corrective action is a shelf-life adjustment rather than a safety defect.
Plain-English summary
Heraeus Medical GmbH (Dental Division) is recalling Heraeus PALAMIX uno dental material (Material Number: 66057893) distributed worldwide, including throughout the US. Long-term stability testing identified 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.
The recall affects approximately 51,771 units with batch numbers below 223060 (UDI-DI: 04260102133587). The manufacturer has reduced the product's shelf life from 3 years to 1.5 years (17 months).
Consumers and healthcare providers in possession of affected product should verify the batch number and discard any units older than 1.5 years from manufacture. Contact Heraeus Medical for further information or to report any related issues.
The recalled product
- Product
- Heraeus, PALAMIX uno. Material Number: 66057893.
- Manufacturer
- Heraeus Medical GmbH (Dental Division)
- Category
- Medical Device — Dental Material
- Hazard
- Affected units
- 51,771
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Material Number: 66057893
- UDI-DI: 04260102133587
- Batch: all batches with numbers below 223060
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Heraeus Medical GmbH (Dental Division) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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