FDA-Device2026-10-07Class IIPACKAGING DEFECT
Heraeus PALACOS MV+G pro bone cement recalled for monomer liquid leakage risk
What this means
Heraeus Medical's PALACOS MV+G pro bone cement products (models 5081290 and 5081291) may leak monomer liquid during use or storage. The cement is used in orthopedic and dental surgical procedures. This issue affects approximately 20,523 units distributed worldwide.
- If you use or stock these products, contact Heraeus Medical for instructions on affected lot numbers and next steps.
- Do not use affected units until you receive guidance from Heraeus Medical or your distributor.
- Report any incidents of leakage or exposure to the FDA's MedWatch program.
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
20,523 units
Manufactured in
Philipp-Reis-Str. 8, Wehrheim, Germany
Products
PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. 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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3303-2026More 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 Medical PALACOS R+G pro bone cement recalled for monomer liquid leakage risk
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