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: 04260102136182, 04260102136212
- 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 R+G pro 40 and 80 are bone cements used in surgical procedures to provide stability and support to bone structures. Healthcare professionals commonly use them during orthopedic surgeries.
Why This Is Dangerous
The breakage of ampoules within the device system prevents the formation of the bone cement dough necessary for proper application during surgery. This can lead to serious complications if not addressed.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may face significant risks during surgical procedures if the bone cement is defective, potentially leading to procedural delays or complications.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the packaging or device.
- Check if the model number is 5081288 or 5081289.
- Verify the recall information against the FDA website.
Where to find product info
Model numbers can typically be found on the product label or packaging.
What timeline to expect
Expect a refund or replacement processing timeline of 4-6 weeks.
If the manufacturer is unresponsive
- Document your communication attempts with the manufacturer.
- Consider contacting regulatory agencies like the FDA for guidance.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Verify product information through official channels.
- Consult healthcare professionals for alternative options.
Documentation advice
Keep records of your purchase, including receipts and any correspondence with the manufacturer.
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Product Details
The recall affects PALACOS R+G pro 40 (Model 5081288) and PALACOS R+G pro 80 (Model 5081289) bone cements. These products are radiopaque, poly(methyl methacrylate)-based bone cements. They were distributed internationally, including countries such as Australia, Belgium, and the United Kingdom.
Key Facts
- Class II medical device
- Stop using the product immediately
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Safety Guide
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