BEUDAMED
    FDA Recall Terminated

    Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve range of shoulder movement and coordination following a stroke, shoulder injury or surgery.

    Recall: Z-1542-2012 · Initiated July 11, 2011

    Recall

    Recall Number
    Z-1542-2012
    Event Number
    61475
    Firm
    North Coast Medical Inc 8100 Camino Arroyo
    FEI Number
    1000124207
    Product Code
    ION
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 11, 2011
    Posted
    May 14, 2012
    Terminated
    September 6, 2012
    Address
    Gilroy, CA, 95020-7304

    Description

    Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve range of shoulder movement and coordination following a stroke, shoulder injury or surgery.

    Reason

    Potential for plastic D-ring to break during use and cause injury.

    Action

    North Coast Medical began contacting customers of the recall on July 13, 2011 by telephone. A phone script was used to inform customers of the affected product, problem, and actions to be taken by the customers. Information was provided for customers to return affected product. Affected devices were re-worked and inspected. Contact the firm by e-mail at www.ncmedical.com for questions regarding this recall.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Switzerland, Germany, Great Britain and the Netherlands.

    Quantity

    2364 units