Z-2208-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2015
- Initiation Date
- July 2, 2015
- Termination Date
- February 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,260 units
Product Description
Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
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.
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.
Code Information
n/a. This action does not involve recall or correction of any device. Only marketing materials are being considered in this action