Recall Z-2208-2015— Silhouette Lift, Inc.

Name: FDA recall Z-2208-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-02

Class II · Terminated

Class II FDA medical device recall by Silhouette Lift, Inc., initiated 2015-07-02, terminated 2016-02-05. It names one FDA 510(k) clearance: K060414. Product: 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..

Recalling firm: Silhouette Lift, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-07-02
Terminated: 2016-02-05
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K060414 — KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTUREKmi Kolster Methods, Inc.·cleared 2006-10-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.