BEUDAMED
    FDA Recall Terminated

    Knee walker, one unit per box. Manufacturer Kenstone Metal (Kunshan) Co., LTD. The intended use is to provide additional mobility to individuals who have difficulty walking.

    Recall: Z-1704-2012 · Initiated April 6, 2012

    Recall

    Recall Number
    Z-1704-2012
    Event Number
    61550
    Firm
    Invacare Corporation
    FEI Number
    3002889431
    Product Code
    ITJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 6, 2012
    Posted
    June 5, 2012
    Terminated
    March 1, 2013
    Address
    1 Invacare Way, Elyria, OH, 44035-4190

    Description

    Knee walker, one unit per box. Manufacturer Kenstone Metal (Kunshan) Co., LTD. The intended use is to provide additional mobility to individuals who have difficulty walking.

    Reason

    Adverse event data prompted testing of device, which revealed that the rod supporting the knee pad was not made to specifications. Upon placing a load on the knee pad, the rod may break or bend causing the walker to collapse. As a result, the user may fall.

    Action

    Invacare notified all consignees and distributors with a "Urgent: Recall Information" letter dated May 16, 2012. The product issue was described and recommended actions were provided to customers. Questions were directed to 1-888-257-7912.

    Distribution

    Worldwide Distribution--USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of China.

    Quantity

    1640