BEUDAMED
    FDA Recall Terminated

    K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.

    Recall: Z-1447-2014 · Initiated March 14, 2014

    Recall

    Recall Number
    Z-1447-2014
    Event Number
    67821
    Firm
    Breg Inc
    FEI Number
    1000125378
    Product Code
    IQI
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    March 14, 2014
    Posted
    April 10, 2014
    Terminated
    April 14, 2014
    Address
    2885 Loker Ave E, Carlsbad, CA, 92010-6626

    Description

    K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.

    Reason

    Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.

    Action

    Breg representatives informed customers of the recall by telephone on March 14, 2014 and then a customer notification letter was sent to customers via email onMarch 17, 2014. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the return response form. Customers with questions are instructed to contact Breg Customer Care at (800) 321-0607.

    Distribution

    USA Nationwide Worldwide in the states of: TX, KY, IN, and FL.

    Quantity

    2 units