Z-2208-2015 Class II Terminated
FDA device recall Z-2208-2015 was initiated by Silhouette Lift, Inc. on July 2, 2015 and is designated Class II. 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 saf… The recall status is terminated (terminated February 5, 2016). Affected quantity: 2,260 units.
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