Device recall
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).
- Recall number
- Z-3301-2026
- Event id
- 99708
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Heraeus Medical GmbH (Dental Division)
- Report date
- Oct 7, 2026
- Posted
- Sep 25, 2026
- Initiated
- Aug 20, 2026
- Center classification date
- Sep 25, 2026
- Product code
- LOD
- Device type
- Bone Cement
- Reason
- Potential for monomer liquid leakage.
- Root cause
- Under Investigation by firm
- Quantity
- 33,727 units
- Code info
- UDI-DI: 04260102136120, 04260102136151. All Batch Numbers. All Lot Numbers.
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K210607
- Location
- Wehrheim, Germany