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.
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
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: E-Mail
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Models affected include PALACOS R pro 40 (Catalog No. 5081286) and PALACOS R pro 80 (Catalog No. 5081287). These products were distributed internationally in several countries, including Australia, Germany, and the UK.
The recall stems from complaints regarding the breakage of ampoules within the application system. If the ampoules do not break correctly, the product cannot be used, leading to potential treatment delays.
The recall was initiated after an undisclosed number of complaints regarding ampoule breakage. No specific injury or incident counts were reported.
Patients and healthcare providers should stop using the affected bone cement immediately. Contact Heraeus Medical GmbH or your healthcare provider for further instructions.
For more information, contact Heraeus Medical GmbH at their official website or through the email notification method provided in the recall.
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