Z-1998-2026Class III

Heraeus, PALAMIX duo. Material Number: 66057897

Name: Z-1998-2026 Heraeus, PALAMIX duo. Material Number: 66057897
Creator: Heraeus Medical GmbH (Dental Division)
Published: 2026-03-25
License: https://open.fda.gov/license/

Heraeus Medical GmbH / initiated 2026-03-25 / Open, Classified

FDA source

Heraeus Medical GmbH (Dental Division) began a recall of Heraeus, PALAMIX duo. Material Number: 66057897 on 2026-03-25. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1998-2026
Classification: Class III
Status: Open, Classified
Initiated: 2026-03-25
Posted: 2026-04-29
Recalling firm: Heraeus Medical GmbH
Product: Heraeus, PALAMIX duo. Material Number: 66057897.
Product code: JDZ Mixer, Cement, For Clinical Use
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).
FDA root cause: Under Investigation by firm
Action: On 03/25/2026 Field Safety Notice letters were sent to customers. Actions to be taken: 1. Read this Field Safety Notice and ensure that all relevant hospital departments are informed about its content. 2. Please complete the attached customer reply form and send it to [email protected] within five (5) calendar days. This form must be returned even if you no longer use the device. 3. Keep a copy of the attached customer reply form with your records in the event of a compliance audit of your facility.
Quantity in commerce: 1,125 units
Distribution: Worldwide 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.;
Product codes and lots: Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1998-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1997-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29
Z-1998-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-05-06	2026-04-29

Product code JDZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)