Silhouette Lift, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2208-2015)
See the recall detail below. You can also see other recalls from the same firm in 2015.
Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
Class II
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.
n/a. This action does not involve recall or correction of any device. Only marketing materials are being considered in this action
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.
Voluntary: Firm initiated