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.
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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The recall affects PALACOS R+G pro 40 (Model 5081288) and PALACOS R+G pro 80 (Model 5081289) bone cements. These products are radiopaque, poly(methyl methacrylate)-based bone cements. They were distributed internationally, including countries such as Australia, Belgium, and the United Kingdom.
Reports indicate an increase in complaints regarding ampoule breakage within the device systems. If none or not all ampoules break, the product cannot be used, leading to potential complications in medical procedures.
There have been multiple incidents reported, though no specific injury or death counts are available. The ampoule breakage can lead to the product being unusable, posing a high-risk factor for patients.
Stop using the affected bone cement immediately. Contact Heraeus Medical GmbH or your healthcare provider for instructions on the recall process.
For more information, contact Heraeus Medical GmbH. Visit the official website or send an email as per the recall instructions.
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