Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brand Name: PALACOS Product Name: PALACOS R pro 40 Recalled by Heraeus Medical GmbH (Dental Division) Due to increase of complaints regarding the breakage of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Heraeus Medical GmbH (Dental Division) directly.
Affected Products
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
Why Was This Recalled?
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.
Where Was This Sold?
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.
About Heraeus Medical GmbH (Dental Division)
Heraeus Medical GmbH (Dental Division) has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report