BEUDAMED
    FDA Recall Terminated

    Victory 10, 3 Wheel (SC610) Mobility medical device

    Recall: Z-3211-2011 · Initiated June 22, 2011

    Recall

    Recall Number
    Z-3211-2011
    Event Number
    59438
    Firm
    Pride Mobility Products Corp
    FEI Number
    3005068474
    Product Code
    INI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 22, 2011
    Posted
    September 14, 2011
    Terminated
    November 20, 2014
    Address
    182 Susquehanna Ave, Exeter, PA, 18643

    Description

    Victory 10, 3 Wheel (SC610) Mobility medical device

    Reason

    Contract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in Pride's Engineering drawings.

    Action

    Pride Mobility Products Corp. sent a "RECALL OF VICTORY 3 AND 4 WHEEL UNITS; REPLACEMENT OF FUSES" letter dated June 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers are asked in the letter to locate their affected Victory unit(s) and inform users of the recall. A letter has been provided by the firm to distribute to users alerting them to the recall. Additionally, customers are to set up an appointment with users to replace the fuses. Customers are instructed to contact Pride's Upgrade department at 866-222-6212 to order the kit and for questions regarding this recall. .

    Distribution

    Worldwide Distribution-USA (nationwide) including the District of Columbia and Puerto Rico and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY and countries of Australia, Canada, France, and United Kingdom.