Heraeus Medical GmbH (Dental Division) — PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and applicati

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

Potential for monomer liquid leakage.

Provider: FDA — device enforcement reference
Source observed: 8/20/2026, 12:00:00 AM UTC
Source updated: 9/25/2026, 12:00:00 AM UTC
Location: Wehrheim, US
hazard: Potential for monomer liquid leakage.
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
product: PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. 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
distribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, Australia, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Japan, Liechtenstein, Malta, Netherlands, New Zealand, Norway, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.
event number: 99708
manufacturer: Heraeus Medical GmbH (Dental Division)
recall number: Z-3304-2026
source status: Open, Classified
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

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