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Terminated

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

FDA Recall Z-2208-2015 · Posted 2015-07-23

Recalling FirmSilhouette Lift, Inc.
Recall StatusTerminated
Product CodeGAM
Date Initiated2015-07-02
Date Terminated2016-02-05
Product Quantity2,260 units

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.

Firm 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.

Root Cause

Labeling False and Misleading

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060414KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTUREKmi Kolster Methods, Inc. · 2006-10-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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