Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in a
FDA device recall Z-2208-2015 · posted 2015-07-23 · Terminated
Recall details
- Recalling firm
- Silhouette Lift, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- GAM
- Quantity affected
- 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.
- Date initiated
- 2015-07-02
- Date posted
- 2015-07-23
- Date terminated
- 2016-02-05
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE (K060414) | Kmi Kolster Methods, Inc. | 2006-10-23 |