Information
Heraeus Medical GmbH (Dental Division) Recalls Heraeus
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #Z-1997-2026Medical Device
Heraeus Medical GmbH (Dental Division) Recalls Heraeus
Heraeus Medical GmbH (Dental Division) · Class III — Regulatory
Product Description
Heraeus, PALAMIX uno. Material Number: 66057893.
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 Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.;
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database