Heraeus Medical GmbH recalled PALACOS MV+G pro 40 and MV+G pro 80 bone cement on December 9, 2025. The recall follows complaints about ampoule breakage, which can prevent proper cement formation. This issue could jeopardize patient safety during medical procedures.
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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This recall affects PALACOS MV+G pro 40 and MV+G pro 80, model numbers 5081290 and 5081291. The products were distributed internationally including in countries like Australia, Germany, and the United Kingdom.
The recall is due to an increase in reports of ampoule breakage within the device systems. If none or not all ampoules break, the product cannot be used, which presents a high risk to patient safety.
There are no specific incident numbers reported. However, the nature of the issue poses a high risk of complications during medical procedures.
Stop using the recalled products immediately. Contact Heraeus Medical GmbH or your healthcare provider for further instructions.
For further assistance, call Heraeus Medical GmbH at the contact number provided on their website or through the email notification method.
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