Reported Jan 21, 2026 · Ongoing
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289…
Heraeus Medical GmbH (Dental Division)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heraeus Medical GmbH (Dental Division) · Philipp-Reis-Str. 8 · Wehrheim · N/A
Is this the product you have?
- Brand NamePALACOS
- Product NamePALACOS R+G pro 40; PALACOS R+G
- pro 80 Model/Catalog Number
50812885081289
- Software VersionN/A
- Product DescriptionRadiopaque, 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)
- ComponentN/A
- Lot codes and dates
- Lot Code
UDI-DI: 0426010213618204260102136212
- Lot Code
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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