Silhouette Lift, Inc. recalls Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in…

Recall date

July 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2208-2015

FDA classification

Class II

Brand / firm

Silhouette Lift, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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