BEUDAMED
    FDA Recall Terminated

    Permolock C3, Docking system for Power wheelchair in vehicle. Intended use: locking device

    Recall: Z-1278-2012 · Initiated February 21, 2012

    Recall

    Recall Number
    Z-1278-2012
    Event Number
    61351
    Firm
    Permobil Inc
    FEI Number
    1221084
    Product Code
    KNN
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    February 21, 2012
    Posted
    March 22, 2012
    Terminated
    August 13, 2013
    Address
    300 Duke Drive, Lebanon, TN, 37090-6005

    Description

    Permolock C3, Docking system for Power wheelchair in vehicle. Intended use: locking device

    Reason

    The fasteners used between June 3, 2011 and January 31, 2012 to attach the Permolock C3 pins to wheelchairs manufactured in the United States do not contain the required nylon ring, which allows for a more secure attachment.

    Action

    The firm, Permobil, sent an "URGENT DEVICE RECALL" letter dated February 27, 2012 via fax to all customers. For those customers where Permobil did not have a valid fax number, the notices were mailed via first class United States mail. The letter describes the product, problem and actions to be taken. Permobil will designate Permobil personnel to complete an update to the Permolock C3 device. If a Permobil representative has not contacted you already, please call 800-736-0925 to schedule the service.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, MD ,MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WV, and WY; and countries of: Australia, Canada, France, Netherlands, Sweden, and United Kingdom.

    Quantity

    147 units