BEUDAMED
    FDA Recall Open, Classified

    Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

    Recall: Z-0582-2026 · Initiated October 17, 2025

    Recall

    Recall Number
    Z-0582-2026
    Event Number
    97753
    Firm
    Straumann USA LLC
    FEI Number
    1000121052
    Product Code
    NQA
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 17, 2025
    Posted
    November 21, 2025
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    Description

    Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

    Reason

    The possibility for this product that is intended for demonstration purposes only to be placed in patients.

    Action

    On October 17, 2025 Urgent Field Safety Action letters were sent to customers. Action to be taken: 1. 1. Check your inventory for the affected article/lot numbers. If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically. Please return the affected items to the attention of Jennifer Jackson at Straumann USA, LLC for credit as indicated on the Customer Confirmation Form. 2. 2. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided. Transmission of the Field Safety Notice This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. The Food and Drug Administration (FDA) has been informed about this Field Safety Corrective Action. We apologize for any inconvenience that this may cause.

    Distribution

    US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.

    Quantity

    61 units