Quick Facts at a Glance
- Recall Date
- December 9, 2025
- Hazard Level
- HIGH
- Brand
- Heraeus Medical GmbH
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Heraeus Medical GmbH
- Product type
- Bone Cement
- Model numbers
- Lot Code: UDI-DI: 04260102136243, 04260102136274
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 9, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
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.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
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.
Practical Guidance
How to identify if yours is affected
- Check if the product model number is 5081290 or 5081291.
- Look for any signs of ampoule breakage in your device systems.
- Consult with your healthcare provider to determine if you have affected products.
Where to find product info
Product model numbers are typically found on the packaging or product label.
What timeline to expect
Expect refund processing to take about 4-6 weeks once initiated.
If the manufacturer is unresponsive
- Document all correspondence with the company.
- Follow up with them via email or phone if you do not receive a timely response.
- Consider filing a complaint with appropriate regulatory bodies if the company remains unresponsive.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Purchase products from reputable suppliers who provide safety information.
- Ask healthcare providers about the safety record of products used in medical procedures.
Documentation advice
Keep copies of receipts, emails, and any correspondence related to the recall for your records.
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Product Details
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.
Key Facts
- Recalled products: PALACOS MV+G pro 40 and MV+G pro 80
- Hazard: Ampoule breakage affects product use
- Stop using the product immediately
- Contact Heraeus Medical for instructions
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Safety Guide
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