BEUDAMED
    FDA Recall Terminated

    Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.

    Recall: Z-0741-2018 · Initiated September 28, 2017

    Recall

    Recall Number
    Z-0741-2018
    Event Number
    78479
    Firm
    Cosmedent, Inc.
    FEI Number
    1450653
    Product Code
    KLE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 28, 2017
    Terminated
    October 5, 2020
    Address
    4646 N Ravenswood Ave, Chicago, IL, 60640-4510

    Description

    Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.

    Reason

    Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.

    Action

    Customers were sent recall notification letters on approximately 09/28/2017. The letter identified the affected device and discussed the reason for the recall. Instructions included discontinuing use of the product, and returning it to Cosmedent. The firm will issue a credit or refund for the recalled device.

    Distribution

    Worldwide Distribution -- USA, to the states of IL, LA, MI, PA, and WI; and, to the countries of Australia, Hungary, and Spain.

    Quantity

    84 units