BEUDAMED
    FDA Enforcement Class III Ongoing

    Heraeus, PALAMIX duo. Material Number: 66057897.

    Recall: Z-1998-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-1998-2026
    Event ID
    98608
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Heraeus Medical GmbH (Dental Division)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2026
    Initiation Date
    March 25, 2026
    Classification Date
    April 29, 2026
    Address
    Philipp-Reis-Str. 8, Wehrheim, N/A, Germany

    Description

    Heraeus, PALAMIX duo. Material Number: 66057897.

    Reason

    Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).

    Code Info

    Material Number: 66057897; UDI-DI: 04260102133617; Batch: all batches with numbers below 520215;

    Distribution

    Worldwide distribution - US Nationwide and the countries of Aland Islands, Algeria, Australia, Austria, Belgium, Brazil , Chile, China, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Kosovo, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Rep. of Korea, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, Uruguay, Utd.Arab Emir.;

    Quantity

    1,125 units