BEUDAMED
    FDA Recall Open, Classified

    KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.

    Recall: Z-1391-2023 · Initiated February 14, 2023

    Recall

    Recall Number
    Z-1391-2023
    Event Number
    91850
    Firm
    Pro-Dex Inc
    FEI Number
    2081135
    Product Code
    GET
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 14, 2023
    Posted
    April 14, 2023
    Address
    2361 McGaw Ave, Irvine, CA, 92614-5831

    Description

    KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.

    Reason

    Incorrect Unique Device Identifier/GTIN code was used on product.

    Action

    On or about 11/08/2022, the firm contacted its customer to inform them that the Unique Device Identifier (UDI/GTIN) code was incorrectly utilized for the the Pro-Dex E-Coupling Adapter Assembly. Customers are instructed to: Immediately cease distribution and us of the affected products. Inventory and distribution records should be evaluated immediately to ensure that affected Return the affected products to Returns Department (Recall CAPA-22-015) Pro-Dex, Inc. 2361 McGaw Avenue Irvine, California 92614 USA Reference the "Recall CAPA-22-015" on the outside of the shipping box For questions or concerns, contact the QARA group at Pro-Dex at 949-769-3200 or email [email protected]

    Distribution

    U.S. Nationwide distribution in the state of FL.

    Quantity

    199 devices