Silhouette Suture Brochure Recalled for Incomplete Risk Information
Silhouette Lift, Inc. is recalling Silhouette Suture brochures because they omit a complete list of risks and side effects, potentially misleading patients about product safety.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score. The hazard is a labeling/documentation error (incomplete risk list) rather than a direct physical defect in the medical device itself, and no injuries or illnesses are reported in the source text.
Plain-English summary
Silhouette Lift, Inc. is recalling the Silhouette Suture brochure. The recall is due to the document failing to include a complete list of risks and side effects associated with the product.
The omission of this information can potentially mislead patients regarding the safety of the Silhouette Sutures, which are used in midface suspension surgery to fixate the cheek subdermis in an elevated position. The source text notes that this action involves only marketing materials and does not involve the recall or correction of the device itself.
The affected brochures were distributed in the United States to the states of CA, TX, IA, MA, RI, GA, WI, PA, VA, MO, FL, NE, MI, NY, and CO, as well as internationally to Canada. The total quantity involved is 2,260 units. Consumers and healthcare providers should be aware that the provided marketing materials do not contain all necessary safety information.
The recalled product
- Product
- Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
- Manufacturer
- Silhouette Lift, Inc.
- Affected units
- 2,260
Distribution
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