BEUDAMED
    FDA Recall 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 · Initiated December 23, 2015

    Recall

    Recall Number
    Z-1095-2016
    Event Number
    73034
    Firm
    Pro-Dex Inc
    FEI Number
    2081135
    Product Code
    MOQ
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    December 23, 2015
    Posted
    March 11, 2016
    Terminated
    July 21, 2017
    Address
    2361 McGaw Ave, Irvine, CA, 92614-5831

    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.

    Action

    A customer notification letter was sent 12/23/15. The letter instructs the customer to cease distribution and use of the recalled lots. It also recommends that the inventory and distribution records be evaluated immediately to ensure that affected product is removed from any potential point of use. Return product to: Returns Department (Recall complaint ClS-001) Pro-Dex, Inc 2361 McGaw Avenue Irvine, California 92614 USA Reference the Recall Complaint # on the outside of the shipping box. If any questions or concerns, please contact the QARA group at Pro-Dex at 949 769 3200.

    Distribution

    Distributed in FL.

    Quantity

    1995 total