FDA Recall Database: Class III Recall: Heraeus, PALAMIX duo. Material Number: 66057897. by Heraeus Medical GmbH (Dental Division)

Key facts

What consumers should do

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Specifically, check whether the product in your possession matches the description on file with FDA -- Heraeus, PALAMIX duo. Material Number: 66057897. -- and the recall number Z-1998-2026. If it matches, stop using or distributing it and contact Heraeus Medical GmbH (Dental Division) or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What this classification means

FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. In this case, the recalling firm is Heraeus Medical GmbH (Dental Division) and the affected product is described in FDA's record as: Heraeus, PALAMIX duo. Material Number: 66057897.. FDA's stated reason for the recall is: 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).. The recall is tracked under FDA recall number Z-1998-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

Heraeus Medical GmbH (Dental Division)’s FDA history

Argus HQ has recorded 2 total FDA actions tied to Heraeus Medical GmbH (Dental Division): 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

How serious is this recall?

FDA classifies a recall as Class III when using the recalled product, or being exposed to it, is not likely to cause any adverse health consequences. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

What should someone who has this product do?

Because FDA considers adverse health consequences unlikely for a Class III recall, the recommended action is still to stop using the product and follow the recalling firm's instructions, since a recall means the product did not meet FDA requirements. Check the product against FDA's description (Heraeus, PALAMIX duo. Material Number: 66057897.) and recall number Z-1998-2026, then follow Heraeus Medical GmbH (Dental Division)'s recall instructions.

Has Heraeus Medical GmbH (Dental Division) had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 2 total FDA actions tied to Heraeus Medical GmbH (Dental Division), including 2 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-1998-2026.

Related enforcement actions