BEUDAMED
    FDA Recall Terminated

    OT1000 Series Orthopedic Surgical Tables

    Recall: Z-1149-2021 · Initiated January 21, 2021

    Recall

    Recall Number
    Z-1149-2021
    Event Number
    87230
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    JEA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 21, 2021
    Terminated
    November 10, 2021
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    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.

    Action

    In January, 2021, Steris will issue an Urgent Medical Device Correction notice to customers via letter for the OT1000 Series Orthopedic Surgical Table. Steris has 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.

    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)