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.
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 bone cement is used in orthopedic surgeries for stabilizing bone structures. It is designed for ease of use in mixing and application during surgical procedures.
The breakage of ampoules can lead to an inability to form the necessary cement dough. This renders the product unusable at the point of application, posing risks for surgical procedures.
This recall is not part of a broader industry pattern.
Consumers who have purchased this product should stop using it immediately. The potential for ineffective surgical procedures creates a significant safety concern.
The model numbers can typically be found on the product label or packaging.
Expect a refund or resolution within 4-6 weeks.
Document all interactions with the manufacturer or healthcare providers related to the recall.
The recalled products include PALACOS MV pro 40 (Model 5150633) and PALACOS MV pro 80 (Model 5150635). The products were distributed internationally in several countries, including Australia, Germany, and the UK.
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