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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The PALACOS bone cement is a poly(methyl methacrylate)-based product used in orthopedic surgeries to fix implants and fill bone cavities. It is favored for its radiopaque properties that aid in imaging during procedures.
The risk arises from the breakage of ampoules that contain the cement. If the ampoules do not break, the necessary cement dough is not formed, rendering the product unusable during surgery.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must stop using the product, which can delay necessary medical procedures and create a risk of complications.
You can find the catalog numbers on the product packaging or accompanying documentation.
Expect a refund or replacement processing time of 4-8 weeks after submitting your request.
Keep a record of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.
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.
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