BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported April 26, 2023

    Enforcement

    Recall Number
    Z-1391-2023
    Event ID
    91850
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Pro-Dex Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2023
    Initiation Date
    February 14, 2023
    Classification Date
    April 14, 2023
    Address
    2361 McGaw Ave, N/A, Irvine, CA, 92614-5831, United States

    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.

    Code Info

    Reference Number: PDEC-1000-2 Part Number: A9671 Lot Numbers: K0C1B, K0D3P, K0E8T, K0FSD, K0HGV

    Distribution

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

    Quantity

    199 devices