Class IIDeviceOngoing

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 cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).

Reason for recall

Potential for monomer liquid leakage.

Details

Recall number: Z-3301-2026
Event ID: 99708
Recall initiated: Aug 20, 2026
Classified: Sep 25, 2026
Reported: Oct 7, 2026
Quantity: 33,727 units
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.
Initiated by: Voluntary: Firm initiated
Firm notification: E-Mail
Firm location: Wehrheim, Germany
Lot / code info: UDI-DI: 04260102136120, 04260102136151. All Batch Numbers. All Lot Numbers.