PALACOS MV+G pro 40 recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIOngoing
Summary: Heraeus Medical GmbH (Dental Division) is recalling 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. Reason: Potential for monomer liquid leakage.
What is being recalled
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
Why
Potential for monomer liquid leakage.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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.
How to tell if yours is affected
Lot Code: UDI-DI: 04260102136243; 04260102136274. All Batch Numbers. All Lot Numbers.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3303-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 20, 2026 |
| Reported | October 7, 2026 |
| Company | Heraeus Medical GmbH (Dental Division) |
| Company location | Wehrheim, Germany |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 20,523 units |
More recalls from Heraeus Medical GmbH (Dental Division) · all medical device recalls · recalls from August 2026