FDA-Device2026-01-21Class IIPROCESSING DEFECT

Heraeus PALACOS MV+G pro bone cement recalled for ampoule breakage

OTHERNationwide distributionMedical devices

What this means

Heraeus Medical's PALACOS MV+G pro bone cement (models 5081290 and 5081291) may have ampoules that fail to break properly during mixing. When ampoules don't break as intended, the cement cannot form correctly and cannot be used during surgery.

Do not use affected PALACOS MV+G pro 40 or pro 80 products (UDI-DI: 04260102136243 or 04260102136274)
Contact Heraeus Medical or your supplier for replacement stock
Check your facility's inventory for affected lot codes

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 MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 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-1082-2026

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