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: 04260102136120, 04260102136151
- 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
The PALACOS bone cement is a poly(methyl methacrylate)-based product used in orthopedic surgeries to fix implants and fill bone cavities. It is favored for its radiopaque properties that aid in imaging during procedures.
Why This Is Dangerous
The risk arises from the breakage of ampoules that contain the cement. If the ampoules do not break, the necessary cement dough is not formed, rendering the product unusable during surgery.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the product, which can delay necessary medical procedures and create a risk of complications.
Practical Guidance
How to identify if yours is affected
- Check the catalog numbers 5081286 and 5081287 on your product packaging.
- Verify the distribution date to see if it falls within the recall period.
- Consult with your healthcare provider regarding the recalled product.
Where to find product info
You can find the catalog numbers on the product packaging or accompanying documentation.
What timeline to expect
Expect a refund or replacement processing time of 4-8 weeks after submitting your request.
If the manufacturer is unresponsive
- Follow up with Heraeus Medical via email or phone if you do not receive a response within a week.
- Document all communications for future reference.
How to prevent similar issues
- When purchasing medical devices, look for products with robust quality assurance and safety records.
- Check for any recent recalls before using medical devices.
- Consult with healthcare professionals about the latest safety information.
Documentation advice
Keep a record of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.
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Product Details
Models affected include PALACOS R pro 40 (Catalog No. 5081286) and PALACOS R pro 80 (Catalog No. 5081287). These products were distributed internationally in several countries, including Australia, Germany, and the UK.
Key Facts
- Models: PALACOS R pro 40, R pro 80
- International distribution in multiple countries
- Class II medical device
- Stop use immediately
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Safety Guide
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