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U.S. Department of Health and Human Services

Class 2 Device Recall Silhouette Lift brochure

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 Class 2 Device Recall Silhouette Lift brochuresee related information
Date Initiated by FirmJuly 02, 2015
Date PostedJuly 23, 2015
Recall Status1 Terminated 3 on February 05, 2016
Recall NumberZ-2208-2015
Recall Event ID 71615
510(K)NumberK060414 
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
ProductSilhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
Code Information n/a.  This action does not involve recall or correction of any device. Only marketing materials are being considered in this action
FEI Number 3007009755
Recalling Firm/
Manufacturer		 Silhouette Lift, Inc.
1 Technology Dr Ste F211
Irvine CA 92618-5336
For Additional Information Contact
951-734-7701
Manufacturer 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.
FDA Determined
Cause 2		Labeling False and Misleading
ActionSilhouette 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 Commerce2,260 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GAM
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