FDAFDA · Food and drugs·Recall number Z-3304-2026
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
Published October 7, 2026 · Recall initiated: August 20, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for monomer liquid leakage.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Heraeus Medical GmbH (Dental Division)
- Distributor
- 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.
- Lot
- Lot Code: UDI-DI: 04260102135338; 04260102135369. All Batch Numbers. All Lot Numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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Questions about this recall
Was 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 recalled?
Yes. FDA published recall Z-3304-2026 on October 7, 2026. Reported hazard: Potential for monomer liquid leakage.
What should I do if I have this product?
Voluntary: Firm initiated · E-Mail
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