PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. 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

Class II

Recalling firm: Heraeus Medical GmbH (Dental Division)
Reason for recall: Potential for monomer liquid leakage.
Affected products (lot / model / serial): Lot Code: UDI-DI: 04260102135338; 04260102135369. All Batch Numbers. All Lot Numbers.
Distribution pattern: 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.
Firm location: Wehrheim, Germany
Recall type: Voluntary: Firm initiated
How the firm notified customers: E-Mail
Product type: Devices
Status: Ongoing
Recall number: Z-3304-2026
Recall initiated: August 20, 2026
FDA classification date: September 25, 2026
FDA report date: October 7, 2026
FDA event ID: 99708
Last updated on HTM Vibe: October 13, 2026