Recall Z-2208-2015 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Silhouette Lift, Inc.
Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
| Date | Jul 23, 2015 (initiated Jul 2, 2015) |
| Status | Terminated |
| 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. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060414 | KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE Kmi Kolster Methods, Inc., Oct 23, 2006 |