Heraeus Medical GmbH (Dental Division): Heraeus, PALAMIX duo. Material Number: 66057897.

Company / brand

Heraeus Medical GmbH (Dental Division)

Product

Heraeus, PALAMIX duo. Material Number: 66057897.

Reason / 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).

Classification

Class III

Status

Ongoing

Distribution / sold at

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.;

Recall initiated

2026-03-25

Code info

Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;

Product quantity

1,125 units

Voluntary mandated

Voluntary: Firm initiated

City

Wehrheim

Country

Germany

Event id

98608

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