BEUDAMED
    FDA Recall Open, Classified

    Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental

    Recall: Z-0154-2024 · Initiated July 18, 2023

    Recall

    Recall Number
    Z-0154-2024
    Event Number
    92867
    Firm
    Preat Corp
    FEI Number
    2918719
    Product Code
    NHA
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    July 18, 2023
    Posted
    October 24, 2023
    Address
    2625 Skyway Dr, Ste B, Santa Maria, CA, 93455-1405

    Description

    Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental

    Reason

    The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

    Action

    On August 4, 2023, Preat Corporation issued a "Urgent Medical Device Recall" notification via: USPS. Preat ask consignees to take the following actions: Product within the scope of the recall shall be discarded or returned to Preat Corporation. Instructions for the return will be provided. Complete and email response form to Nichole Fetterman, E-Mail: [email protected] or mail to Preat Corporation, Attn. Nichole Fetterman, 2625 Skyway Drive, Ste. B, Santa Maria, CA 93455

    Distribution

    US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None

    Quantity

    4 units