FDA recall, , Moderate risk
PALACOS Bone Cement Mixing and Application Systems
Palacos bone cement may have ampoules that do not break, so the product cannot be used on the patient.
Summary by Recall Canary from the FDA notice
What happened
Heraeus Medical GmbH (Dental Division) of Wehrheim, Germany, recalled Palacos MV+G pro 40, Palacos R pro 40, Palacos MV pro 40, and Palacos R+G pro 40 radiopaque poly(methyl methacrylate)-based bone cements, pre-filled into a mixing and application system, due to an increase of complaints regarding breakage of the ampoules within their device systems.
An extensive investigation revealed that multiple factors impact ampoule breakage, and 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.
The recall began December 9, 2025, and was added to the FDA's Enforcement Report on January 14, 2026. Distribution was international, including Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Affected if its UDI-DI and model/catalog number are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
PALACOS MV+g Pro 40; PALACOS MV+g Pro 80
- UDI-DI
- 04260102136243
- 04260102136274
- Model/Catalog number
- 5081290
- 5081291
PALACOS R Pro 40; PALACOS R Pro 80
- UDI-DI
- 04260102136120
- 04260102136151
- Model/Catalog number
- 5081286
- 5081287
PALACOS MV Pro 40; PALACOS MV Pro 80
- UDI-DI
- 04260102135338
- 04260102135369
- Model/Catalog number
- 5150633
- 5150635
PALACOS R+g Pro 40; PALACOS R+g Pro 80
- UDI-DI
- 04260102136182
- 04260102136212
- Model/Catalog number
- 5081288
- 5081289
Recall details
- Company began the recall
- Sold in
International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.
- Company
- Heraeus Medical GmbH (Dental Division)Wehrheim, Germany
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98078
- Recall numbers
- Z-1080-2026 to Z-1083-2026
All recalls from Heraeus Medical GmbH (Dental Division)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
