Events

Recall of Device Recall Silhouette Lift brochure

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Silhouette Lift, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71615
  • Event Risk Class
    Class 2
  • Event Number
    Z-2208-2015
  • Event Initiated Date
    2015-07-02
  • Event Date Posted
    2015-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138409
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
  • 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.

Device

Device Recall Silhouette Lift brochure
  • Model / Serial
    n/a.  This action does not involve recall or correction of any device. Only marketing materials are being considered in this action
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Product Description
    Silhouette Lift brochure || Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
  • Manufacturer
    Silhouette Lift, Inc.

Manufacturer

Silhouette Lift, Inc.
  • Manufacturer Address
    Silhouette Lift, Inc., 1 Technology Dr Ste F211, Irvine CA 92618-5336
  • Manufacturer Parent Company (2017)
    Silhouette Lift Inc.
  • Source
    USFDA