FDA-Device2026-01-21Class IIPROCESSING DEFECT

Heraeus Medical PALACOS R+G pro bone cement recalled for ampoule breakage

OTHERNationwide distributionMedical devices

What this means

Heraeus Medical is recalling PALACOS R+G pro bone cement (models 5081288 and 5081289) because the ampoules inside the mixing system may fail to break properly. When ampoules don't break as intended, the cement cannot be prepared correctly for use during surgery.

Stop using affected lots immediately
Contact Heraeus Medical for instructions on returned or replacement product
Verify your product's lot code matches the recall notice before use

The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

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+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 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-1081-2026

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