BEUDAMED
    FDA Enforcement Class II Terminated

    Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    Recall: Z-1095-2016 · Reported March 23, 2016

    Enforcement

    Recall Number
    Z-1095-2016
    Event ID
    73034
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pro-Dex Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 23, 2016
    Initiation Date
    December 23, 2015
    Classification Date
    March 11, 2016
    Termination Date
    July 21, 2017
    Address
    2361 McGaw Ave, Irvine, CA, 92614-5831, United States

    Description

    Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    Reason

    The sterile battery may contain particulates within the sterile package.

    Code Info

    Lots 509567, K055R

    Distribution

    Distributed in FL.

    Quantity

    1995 total