TemporaryFDAOngoing
Can cause harm that is usually temporary.
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).
Check the device or its packaging for
UDI-DI: 04260102136120, 04260102136151. All Batch Numbers. All Lot Numbers.
- Why
- Potential for monomer liquid leakage.
- Distributed
- 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.
- Company
- Heraeus Medical GmbH (Dental Division)
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3301-2026 · retrieved 25 September 2026
Read the official notice