BEUDAMED
    FDA Recall Terminated

    Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.

    Recall: Z-2208-2015 · Initiated July 2, 2015

    Recall

    Recall Number
    Z-2208-2015
    Event Number
    71615
    Firm
    Silhouette Lift, Inc.
    FEI Number
    3007009755
    Product Code
    GAM
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    July 2, 2015
    Posted
    July 23, 2015
    Terminated
    February 5, 2016
    Address
    1 Technology Dr, Ste F211, Irvine, CA, 92618-5336

    Description

    Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.

    Reason

    Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a complete list of risks and side effects. Therefore, it can potentially mislead the patient regarding the safety of the product.

    Action

    Silhouette lift sent an "Correction of Information for Silhouette Suture" letter dated July 2, 2015, in response to FDA untitled letter. The letter identified the product the problem and the action needed to be taken by the customer. Action Requested: All brochures for Silhouette Suture should be destroyed and no longer be used for discussions with patients. Customers with questions are instructed to call (951) 734-7701.

    Distribution

    US Distribution to the states of : CA, TX, IA, MA, RI, GA, WI, PA, VA, MO, FL, NE, MI, NY and CO., and Internationally to Canada.

    Quantity

    2,260 units