BEUDAMED
    FDA Enforcement Class II Terminated

    OT1000 Series Orthopedic Surgical Tables

    Recall: Z-2248-2016 · Reported July 27, 2016

    Enforcement

    Recall Number
    Z-2248-2016
    Event ID
    74264
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 27, 2016
    Initiation Date
    May 23, 2016
    Classification Date
    July 20, 2016
    Termination Date
    August 22, 2016
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    Description

    OT1000 Series Orthopedic Surgical Tables

    Reason

    STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly.

    Code Info

    OT1000, OT1100, and OT1200 Orthopedic Surgical Table

    Distribution

    AL;AK, AZ; AR; CA; CO; CT; DC; FL; GA; IL; IN; IA; NY; NJ; NC; OH; OK; OR; PA; PR; SC; TX; UT and VA. Foreign accounts: Canada; France; Korea; Panama; Qatar and Thailand.

    Quantity

    148