Heraeus Medical GmbH (Dental Division) recalls PALACOS R pro 40
- Recalling company
- 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
- Potential for monomer liquid leakage.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 20, 2026
- Reported
- Oct 7, 2026
- Distribution
- 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.
- Status
- Ongoing
- Quantity
- 33,727 units
- Lot / codes
- UDI-DI: 04260102136120, 04260102136151. All Batch Numbers. All Lot Numbers.
- Company location
- Wehrheim
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3301-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3301-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.