BEUDAMED
    FDA Recall Terminated

    OT1000 Series Orthopedic Surgical Tables

    Recall: Z-2248-2016 · Initiated May 23, 2016

    Recall

    Recall Number
    Z-2248-2016
    Event Number
    74264
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    JEA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 23, 2016
    Terminated
    August 22, 2016
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    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.

    Action

    Recall Notification Letters to the affected Consignees was sent on May 23, 2016 via FedEx with tracking numbers for delivery confirmation. STERIS Field Service Technicians will visit each domestic Customer location to perform the inspection and reinstallation of the pivot pin assemblies. For international direct accounts who have further distributed the surgical table, Steris asked to identify the Customers, and to notify them of this product field correction, and that not to operate the tables until the inspection has been done of the pivot pin assembly on all affected tables.

    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