BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 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

    Recall: Z-1080-2026 · Reported January 21, 2026

    Enforcement

    Recall Number
    Z-1080-2026
    Event ID
    98078
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Heraeus Medical GmbH (Dental Division)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 21, 2026
    Initiation Date
    December 9, 2025
    Classification Date
    January 14, 2026
    Address
    Philipp-Reis-Str. 8, Wehrheim, N/A, Germany

    Description

    Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 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

    Reason

    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.

    Code Info

    Lot Code: UDI-DI: 04260102136120; 04260102136151

    Distribution

    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.