Heraeus Medical GmbH (Dental Division) recalls PALACOS MV pro 40
Potential for monomer liquid leakage.
- Bone Cement
- Under Investigation by firm
The FDA has posted 6 enforcement recalls of bone cement devices since 2025, none of them Class I (most serious). Most recent report: Oct 7, 2026.
Potential for monomer liquid leakage.
Potential for monomer liquid leakage.
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.…
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.…
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.…
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.…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Bone Cement”). Informational only — verify against the FDA before acting.