Heraeus PALACOS Bone Cement Mixing and Application Systems
Palacos R pro bone cement has a potential for monomer liquid leakage.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Heraeus Medical GmbH (Dental Division) recalled Palacos MV+G pro 40, Palacos MV pro 40, Palacos R pro 40, and Palacos R+G pro 40 bone cement products due to potential for monomer liquid leakage. The recall began August 20, 2026, and was added to FDA's Enforcement Report on September 25, 2026.
Summary by Recall Canary from the FDA notice.
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 your mix affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Product details
PALACOS MV pro 40;
PALACOS MV pro 80. Model/Catalog Number: 5150633;
5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A- UDI-DI
- 04260102135338
- 04260102135369
- Lot
- All Lot Numbers.
Product details
PALACOS R pro 40;
PALACOS R pro 80. Model/Catalog Numbers: 5081286;
5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).- UDI-DI
- 04260102136120
- 04260102136151
- Lot
- All Lot Numbers.
Product details
PALACOS R+G pro 40;
PALACOS R+G pro 80. Model/Catalog Number: 5081288;
5081289. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).- UDI-DI
- 04260102136182
- 04260102136212
- Lot
- All Lot Numbers.
Product details
PALACOS MV+G pro 40;
PALACOS MV+G pro 80. Model/Catalog Number: 5081290;
5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A- UDI-DI
- 04260102136243
- 04260102136274
- Lot
- All Lot Numbers.
Details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.
- Event ID
- 99708
- Recall numbers
- Z-3301-2026 to Z-3304-2026
- Company
- Heraeus Medical GmbH (Dental Division)Wehrheim, Germany
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
