BEUDAMED
    FDA Enforcement Class II Terminated

    EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide Operating Table General Purpose Surgical Table

    Recall: Z-1844-2016 · Reported June 8, 2016

    Enforcement

    Recall Number
    Z-1844-2016
    Event ID
    74128
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Skytron, Div. The KMW Group, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2016
    Initiation Date
    April 6, 2016
    Classification Date
    May 31, 2016
    Termination Date
    July 20, 2017
    Address
    5085 Corporate Exchange Blvd SE, N/A, Grand Rapids, MI, 49512-5515, United States

    Description

    EZ Slide Battery/line powered hydraulic table with removable leg section and 21 top slide General Purpose Surgical Table Skytron EZ Slide Operating Table General Purpose Surgical Table

    Reason

    The potential exists within the identified tables that incorrectly manufactured parts have been used in assembly. If a table is found to have these incorrectly manufactured parts, it is possible for the tables elevation column slide cap to become detached from the elevation column and could result in the loss of control of the table top and injury to the patient or staff.

    Code Info

    Model number 3502. All units. Units entered commercial distribution between April 30, 2014 and July 24, 2014

    Distribution

    Nationwide Distribution to AL, AZ, CO, IA, WI, PA, TN, MA, TX, MI, FL, MS, LA, and CA.

    Quantity

    458