FDA-Device2026-10-07Class IIPACKAGING DEFECT
Heraeus Medical PALACOS R+G pro bone cement recalled for monomer liquid leakage risk
What this means
Heraeus Medical is recalling PALACOS R+G pro 40 and R+G pro 80 bone cement products because the pre-filled mixing systems may leak monomer liquid during use. The affected products are used in orthopedic and other surgical procedures. This recall affects units distributed worldwide, including throughout the US.
- If you have received or used these products, stop use immediately and contact Heraeus Medical or your hospital pharmacy.
- Report any incidents of leakage or monomer exposure to Heraeus Medical and the FDA.
- Check your facility's inventory against the affected lot numbers and UDI codes provided in the recall notice.
The agency's original wording
Hazard
Potential for monomer liquid leakage.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
59,660 units
Manufactured in
Philipp-Reis-Str. 8, Wehrheim, Germany
Products
PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. 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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3302-2026More Heraeus recalls
- FDA-Device2026-10-07Heraeus Medical PALACOS R pro bone cement recalled for monomer liquid leakage risk
- FDA-Device2026-10-07Heraeus Medical PALACOS MV pro bone cement recalled for monomer liquid leakage risk
- FDA-Device2026-10-07Heraeus PALACOS MV+G pro bone cement recalled for monomer liquid leakage risk
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