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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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.
Breakage of ampoules within the device systems can occur due to multiple influencing factors. If the ampoules do not break, no appropriate cement dough is formed, making the product ineffective for patient use.
There have been multiple complaints regarding ampoule breakage, but no specific injury or death counts have been reported.
Stop using the PALACOS bone cement immediately. Follow the recall instructions provided by Heraeus Medical GmbH and contact your healthcare provider for further instructions.
For more information, contact Heraeus Medical GmbH (Dental Division) via email. Further details can be found at the official FDA recall page.
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