Heraeus Medical GmbH (Dental Division): PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cem
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- Company / brand
- Heraeus Medical GmbH (Dental Division)
- Product
- 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).
- Reason / hazard
- Potential for monomer liquid leakage.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-08-20
- Code info
- UDI-DI: 04260102136120, 04260102136151. All Batch Numbers. All Lot Numbers.
- Product quantity
- 33,727 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Wehrheim
- Country
- Germany
- Event id
- 99708
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