Device product
Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
Z-2208-2015
Product summary
- Event
- Event 71615
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,260 units
- Official record key
device-enforcement:Z-2208-2015
Official wording
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.
Code information: n/a. This action does not involve recall or correction of any device. Only marketing materials are being considered in this action
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.
Derived failure modes
-
Unknown
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.