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FDA-Device2026-01-21Class IIPROCESSING DEFECT

Heraeus PALACOS R pro bone cement recalled for ampoule breakage

Heraeus
OTHERNationwide distribution

Stop using PALACOS R pro bone cement

Heraeus Medical is recalling PALACOS R pro 40 and R pro 80 bone cement products because the ampoules (small sealed containers) inside the mixing systems may not break properly during use. When ampoules fail to break, the bone cement cannot be prepared correctly and cannot be used during surgery.

  • Stop using any PALACOS R pro 40 or R pro 80 units with lot codes matching UDI-DI 04260102136120 or 04260102136151
  • Contact Heraeus Medical or your surgical supplier for instructions on how to return or dispose of affected units
  • Consult with your facility's surgical team if this product was recently used in procedures
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 R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 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-1080-2026

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