BEUDAMED
    FDA Enforcement Class II Terminated

    Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.

    Recall: Z-0810-2013 · Reported February 20, 2013

    Enforcement

    Recall Number
    Z-0810-2013
    Event ID
    63991
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mizuho OSI
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2013
    Initiation Date
    December 17, 2012
    Classification Date
    February 13, 2013
    Termination Date
    April 15, 2016
    Address
    30031 Ahern Ave, Union City, CA, 94587-1234, United States

    Description

    Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.

    Reason

    Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. If this occurs, the Orthopedic Table Spar may need to be replaced to ensure stability of the Orthopedic Table Top.

    Code Info

    Table model 5855, sub assembly 5855-901 Orthopedic Table Spar, manufactured between 1996 and 2007.

    Distribution

    USA Distribution -- Worldwide Distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Canada, Egypt, Finland, France, Germany, China, Israel, Italy, Japan, Netherlands, New Zealand, P.R. China, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Taiwan R.O.C., UAE and UK.

    Quantity

    869 devices