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Recall Observatory FDA recall evidence

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

July 02, 2015

Class II

Product summary

Firm
Silhouette Lift, Inc.
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

    reason.no_named_rule · v1.0.0

    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.