FDA-Device2026-10-07Class IIPACKAGING DEFECT
Heraeus Medical PALACOS MV pro bone cement recalled for monomer liquid leakage risk
What this means
Heraeus Medical is recalling PALACOS MV pro 40 and PALACOS MV pro 80 bone cement products due to a potential for monomer liquid to leak from the pre-filled mixing and application system. The leakage could occur during handling or use in surgical procedures.
- If you have these products, stop using them and quarantine the affected batches.
- Check the model numbers (5150633 or 5150635) and lot codes (UDI-DI: 04260102135338 or 04260102135369) on your inventory.
- Contact Heraeus Medical or your supplier for instructions on return or replacement.
- Consult with your facility's quality or regulatory team for next steps.
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.
Manufactured in
Philipp-Reis-Str. 8, Wehrheim, Germany
Products
PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. 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-3304-2026More Heraeus recalls
- FDA-Device2026-10-07Heraeus Medical PALACOS R pro bone cement recalled for monomer liquid leakage risk
- FDA-Device2026-10-07Heraeus Medical PALACOS 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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