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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PALACOS R+G pro 40 and 80 are bone cements used in surgical procedures to provide stability and support to bone structures. Healthcare professionals commonly use them during orthopedic surgeries.
The breakage of ampoules within the device system prevents the formation of the bone cement dough necessary for proper application during surgery. This can lead to serious complications if not addressed.
This recall is not part of a broader industry pattern.
Patients may face significant risks during surgical procedures if the bone cement is defective, potentially leading to procedural delays or complications.
Model numbers can typically be found on the product label or packaging.
Expect a refund or replacement processing timeline of 4-6 weeks.
Keep records of your purchase, including receipts and any correspondence with the manufacturer.
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.
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