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Heraeus Medical GmbH (Dental Division) recalls Heraeus, PALAMIX uno. Material Number: 66057893.
Recalled May 6, 2026 · FDA recall Z-1997-2026 · Heraeus Medical GmbH (Dental Division)
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). · FDA Class III
Units
51,771 units
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.;
Description
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).
Product
Heraeus, PALAMIX uno. Material Number: 66057893.
Manufacturer(s)
Heraeus Medical GmbH (Dental Division)
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →