BEUDAMED
    FDA Recall Open, Classified

    Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714

    Recall: Z-0725-2023 · Initiated December 5, 2022

    Recall

    Recall Number
    Z-0725-2023
    Event Number
    91173
    Firm
    Young Dental Manufacturing I, LLC
    FEI Number
    1941138
    Product Code
    JET
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    December 5, 2022
    Posted
    December 19, 2022
    Address
    13705 Shoreline Ct E, Earth City, MO, 63045-1202

    Description

    Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714

    Reason

    mislabeled product

    Action

    The firm issued an URGENT: MEDICAL DEVICE RECALL notice on 12/05/2022 to its consignees be certified mail. The notice explains the issue and requests either the return or discarding of the affected product. The response form indicates that their customers will be notified. On 12/19/2022, firm expanded recall to include an additional affected lot. Customers were sent an updated URGENT: MEDICAL DEVICE RECALL notice on 12/19/2022, which included the same instructions.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of IA, NY, PA, TN, TX, and the country of Canada.

    Quantity

    600 packs