BEUDAMED
    FDA Enforcement Class II 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 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2208-2015
    Event ID
    71615
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Silhouette Lift, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2015
    Initiation Date
    July 2, 2015
    Classification Date
    July 23, 2015
    Termination Date
    February 5, 2016
    Address
    1 Technology Dr Ste F211, N/A, Irvine, CA, 92618-5336, United States

    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.

    Code Info

    n/a. This action does not involve recall or correction of any device. Only marketing materials are being considered in this action

    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