Reported Jul 29, 2015 · Terminated
Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in…
Silhouette Lift, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Silhouette Lift, Inc. · 1 Technology Dr Ste F211 · Irvine, CA · 92618-5336
Is this the product you have?
- Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.
- Lot codes and dates
- n/a. This action does not involve recall or correction of any device. Only marketing materials are being considered in this action
- Amount recalled
- 2,260 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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