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: 04260102135338, 04260102135369
- 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 used in orthopedic surgeries for stabilizing bone structures. It is designed for ease of use in mixing and application during surgical procedures.
Why This Is Dangerous
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.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers who have purchased this product should stop using it immediately. The potential for ineffective surgical procedures creates a significant safety concern.
Practical Guidance
How to identify if yours is affected
- Check the model numbers: 5150633 and 5150635.
- Confirm the product packaging for the recall notice.
- Contact your healthcare provider for confirmation.
Where to find product info
The model numbers can typically be found on the product label or packaging.
What timeline to expect
Expect a refund or resolution within 4-6 weeks.
If the manufacturer is unresponsive
- Follow up with Heraeus Medical via email.
- Keep a record of all communications.
How to prevent similar issues
- Research product safety certifications before purchase.
- Consult with healthcare professionals on alternative products.
- Stay informed about recalls in the medical device industry.
Documentation advice
Document all interactions with the manufacturer or healthcare providers related to the recall.
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Product Details
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.
Key Facts
- Recall date: December 9, 2025
- High hazard level
- Immediate stop-use advised
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Safety Guide
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