BEUDAMED
    FDA Recall Terminated

    Cervical Extension Machine for Physical Therapy

    Recall: Z-0936-2015 · Initiated December 3, 2013

    Recall

    Recall Number
    Z-0936-2015
    Event Number
    69422
    Firm
    MedX Holdings, Inc.
    FEI Number
    1051095
    Product Code
    IKK
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    December 3, 2013
    Posted
    January 7, 2015
    Terminated
    September 29, 2016
    Address
    839 Nw 25th Ave, Ocala, FL, 34475-5789

    Description

    Cervical Extension Machine for Physical Therapy

    Reason

    Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on these devices during manufacturing.

    Action

    Medx began contacting its consignees December 30, 2013, to schedule testing on the devices at their facility. The technician has been scheduled to complete required testing of these devices in the field. For questions regarding this recall call 322-351-2005.

    Distribution

    Worldwide Distribution - USA including MO, IL, ID, and MN and Internationally to Germany and South Korea.

    Quantity

    4