BEUDAMED
    FDA Recall Open, Classified

    CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles

    Recall: Z-0285-2024 · Initiated October 6, 2023

    Recall

    Recall Number
    Z-0285-2024
    Event Number
    93176
    Firm
    Young Dental Manufacturing I, LLC
    FEI Number
    1941138
    Product Code
    EGS
    Status
    Open, Classified
    Root Cause
    Packaging process control
    Initiated
    October 6, 2023
    Posted
    November 9, 2023
    Address
    13705 Shoreline Ct E, Earth City, MO, 63045-1202

    Description

    CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles

    Reason

    one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.

    Action

    Young Dental Manufacturing CO 1, LLC issued a MEDICAL DEVICE RECALL notice to its consignees on 10/06/2023 by USPS certified mail with return receipt notification. The notice explained the issue and requested that the product be returned or destroyed. Distributors were directed to notify their customers. Replacement product will be provided directly from the recalling firm; refunds will be handled through the distributor and credit issued.

    Distribution

    US: IN, TN, MO

    Quantity

    12 units