BEUDAMED
    FDA Enforcement Class II Terminated

    OT1000 Series Orthopedic Surgical Tables

    Recall: Z-1149-2021 · Reported March 3, 2021

    Enforcement

    Recall Number
    Z-1149-2021
    Event ID
    87230
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 3, 2021
    Initiation Date
    January 21, 2021
    Classification Date
    February 24, 2021
    Termination Date
    November 10, 2021
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    Description

    OT1000 Series Orthopedic Surgical Tables

    Reason

    On January 7, 2021, STERIS identified that the glued bond between the beam and the leg spar assembly may begin to separate over time. This could result in unexpected movement of the affected leg spar if the separation occurred during a patient procedure.

    Code Info

    Model No.: OT1000, OT1100, OT1200

    Distribution

    Domestic: AL, AK, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL IN, IW, KS, KY, LA, ME, MD, MI, MN, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, PR, SC, TX, UT, VT, VA, WA, WV, WI. Foreign: Canada, South Korea, Panama, Qatar, Thailand.

    Quantity

    272 tables total (Domestic: 227 tables, Foreign 45 tables)