FDA-Device2015-07-29Class II

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

Silhouette Lift, Inc.
Hazard

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.

Sold states
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.
Affected count
2,260 units
Manufactured in
1 Technology Dr Ste F211, N/A, Irvine, CA, United States
Products
Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2208-2015

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