BEUDAMED
    FDA Recall Terminated

    OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series 6800 and 6822 included)

    Recall: Z-0243-2008 · Initiated February 28, 2007

    Recall

    Recall Number
    Z-0243-2008
    Event Number
    38307
    Firm
    Mizuho Orthopedic Systems Inc
    FEI Number
    2921578
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 28, 2007
    Posted
    December 13, 2007
    Terminated
    December 18, 2008
    Address
    30031 Ahern Ave, Union City, CA, 94587-1234

    Description

    OSI, 6822 IntraOp Series Tables, Operating Room tables, Orthopedic Systems, Inc., Union City, CA. (Series 6800 and 6822 included)

    Reason

    Failure to anchor; due to a failure in the locking mechanism, the product may not anchor properly.

    Action

    The firm issued a Product Correction Notification letter by mail on 02/28/2007 and follow up with phone calls. The letter notified users that a required no-cost upgrade of the removal and replacement of a microprocessor that controls the logic for the floor locking mechanism will be conducted by the recalling firm.

    Distribution

    Worldwide: USA product was distributed to 16 wholesale dealers, 212 medical facilities, 14 distributors throughout the US in the following states: AL, AZ, CA, FL, GA, HI, IL, IN, KS, KY, MA, MD, ME, MI, MO, NC, NE, NH, NJ, NM, NY, OH, OR, PA, SC, TX, VA, WA, WI, WV and WY and to the following countries Taiwan, Australia, German, Japan, Canada, Saudi Arabia, and The UK.

    Quantity

    117 units