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).
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).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Heraeus Medical GmbH (Dental Division) or your healthcare provider for instructions. Notification method: Letter
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Heraeus, PALAMIX uno. Material Number: 66057893.. Reason: 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. Quantity: 51,771 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.;
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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).
Heraeus Medical GmbH recalled PALACOS R+G pro 40 and 80 bone cements on December 9, 2025. The recall follows multiple reports of ampoule breakage that prevent proper use of the product. Patients and healthcare providers must stop using the affected devices immediately.
Heraeus Medical GmbH recalled PALACOS MV+G pro 40 and MV+G pro 80 bone cement on December 9, 2025. The recall follows complaints about ampoule breakage, which can prevent proper cement formation. This issue could jeopardize patient safety during medical procedures.
Heraeus Medical GmbH recalled PALACOS MV pro 40 and MV pro 80 bone cement on December 9, 2025. The recall follows numerous complaints about ampoule breakage. This defect can prevent proper cement dough formation, rendering the product unusable for patients.
Heraeus Medical GmbH recalled PALACOS R pro 40 and R pro 80 bone cement on December 9, 2025. The recall follows multiple complaints of ampoule breakage affecting product usability. Healthcare providers must stop using the product immediately.