FDA-Device2026-10-07Class IIPACKAGING DEFECT
Heraeus Medical PALACOS R pro bone cement recalled for monomer liquid leakage risk
What this means
Heraeus Medical is recalling PALACOS R pro 40 and PALACOS R pro 80 bone cement systems due to potential leakage of monomer liquid from the pre-filled mixing cartridges. Monomer liquid exposure during dental or orthopedic surgery could affect the procedure or patient safety.
- If you have these products in inventory, stop using them immediately.
- Contact Heraeus Medical for instructions on return or disposal.
- Check product labels for model numbers 5081286 or 5081287 and the UDI-DI numbers listed in this recall.
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
33,727 units
Manufactured in
Philipp-Reis-Str. 8, Wehrheim, Germany
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3301-2026More Heraeus recalls
- FDA-Device2026-10-07Heraeus Medical PALACOS MV pro bone cement recalled for monomer liquid leakage risk
- FDA-Device2026-10-07Heraeus Medical PALACOS R+G 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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