Z-2208-2015Class II

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

Name: Z-2208-2015 Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek...
Creator: Silhouette Lift, Inc.
Published: 2015-07-02
License: https://open.fda.gov/license/

Sinclair Pharma US, Inc. / initiated 2015-07-02 / Terminated / root cause: labeling and UDI

FDA source

Silhouette Lift, Inc. began a recall of Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position on 2015-07-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2208-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-02
Posted: 2015-07-23
Terminated: 2016-02-05
Recalling firm: Sinclair Pharma US, Inc.
Product: Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
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.
Quantity in commerce: 2,260 units
Distribution: 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.
Product codes and lots: n/a. This action does not involve recall or correction of any device. Only marketing materials are being considered in this action

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2208-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2208-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-23

Product code GAM

K060414Class IIKolster Methods, Inc., Featherlift Silhouette SutureKmi Kolster Methods, Inc. / cleared 2006-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)