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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PALACOS bone cement is commonly used in orthopedic surgeries to secure implants and support bone healing. The cement is essential in procedures where stable fixation is required.
The ampoules that contain the cement are prone to breakage, which can prevent the formation of the necessary cement dough for medical use, jeopardizing patient safety.
This recall is not part of a broader industry pattern.
Patients and healthcare providers face significant safety risks due to the potential failure of the product to perform as intended, which could lead to serious complications during surgery.
Product model numbers are typically found on the packaging or product label.
Expect refund processing to take about 4-6 weeks once initiated.
Keep copies of receipts, emails, and any correspondence related to the recall for your records.
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.
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