BEUDAMED
    FDA Recall Open, Classified

    FG 57 100057X (100057X)

    Recall: Z-0465-2021 · Initiated October 20, 2020

    Recall

    Recall Number
    Z-0465-2021
    Event Number
    86694
    Firm
    Coltene Whaledent Inc
    FEI Number
    2416455
    Product Code
    EJL
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 20, 2020
    Address
    235 Ascot Pkwy, Cuyahoga Falls, OH, 44223-3701

    Description

    FG 57 100057X (100057X)

    Reason

    The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.

    Action

    On October 20, 2020, the firm emailed Urgent Medical Device Recall letters to affected distributors. Customers were informed that the incorrect dental carbide bur was manufactured and subsequently packaged and distributed. Customers were asked to return the product to Coltene/Whaledent, Inc. by following the instructions in the letter. The firm will replace the product at no cost. Please inform the firm if you have already used the product. Distributors were asked to either identify and notify their customers who were shipped the affected product or to provide a list of affected customers to the recalling firm so that Coltene/Whaledent, Inc. could notify them.

    Distribution

    Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.

    Quantity

    556