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FDA-Device2026-01-21Class IIPROCESSING DEFECT

Heraeus PALACOS MV pro bone cement recalled for ampoule breakage

Heraeus
OTHERNationwide distribution

Stop using Heraeus PALACOS MV pro cement

Heraeus Medical's PALACOS MV pro bone cement systems (models 5150633 and 5150635) have experienced increased reports of ampoule breakage during use. When ampoules fail to break properly or incompletely, the cement cannot form correctly and cannot be used in surgery.

  • Stop using affected PALACOS MV pro 40 and PALACOS MV pro 80 systems immediately
  • Check your inventory for UDI codes 04260102135338 or 04260102135369
  • Contact Heraeus Medical or your supplier for instructions on returns or replacements
  • Consult your facility's recall protocol before any scheduled procedures using this product
Hazard

increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.

Sold states
International distribution in the countries of Aland Islands, Australia, Belgium, Denmark, Finland, Germany, Ireland, Italy, Liechtenstein, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom.
Manufactured in
Philipp-Reis-Str. 8, Wehrheim, Germany
Products
Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: 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-1083-2026

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