BEUDAMED
    FDA Recall Open, Classified

    Heraeus, PALAMIX duo. Material Number: 66057897.

    Recall: Z-1998-2026 · Initiated March 25, 2026

    Recall

    Recall Number
    Z-1998-2026
    Event Number
    98608
    Firm
    Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany
    FEI Number
    3006406161
    Product Code
    JDZ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 25, 2026
    Posted
    April 29, 2026

    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).

    Action

    On 03/25/2026 Field Safety Notice letters were sent to customers. Actions to be taken: 1. Read this Field Safety Notice and ensure that all relevant hospital departments are informed about its content. 2. Please complete the attached customer reply form and send it to [email protected] within five (5) calendar days. This form must be returned even if you no longer use the device. 3. Keep a copy of the attached customer reply form with your records in the event of a compliance audit of your facility.

    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