Heraeus Medical GmbH (Dental Division) recalls Brand Name: PALACOS Product Name: PALACOS R pro 40
- Recalling company
- Heraeus Medical GmbH (Dental Division)
- Product
- Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: 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
- increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 9, 2025
- Reported
- Jan 21, 2026
- Distribution
- International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.
- Status
- Ongoing
- Lot / codes
- Lot Code: UDI-DI: 04260102136120; 04260102136151
- Company location
- Wehrheim
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1080-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1080-2026 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.