Silhouette Lift brochure Silhouette Sutures are for use in midface… — Class II medical device recall Z-2208-2015
Terminated recall by Silhouette Lift, Inc., reported 2015-07-29, distributed in CA, CO, FL, GA, IA, MA, MI, MO…. Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a complete list of ris
| Recall number | Z-2208-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Silhouette Lift, Inc., Irvine, CA, United States |
| Recall initiated | 2015-07-02 |
| Classified | 2015-07-23 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2016-02-05 |
| Distributed | CA, CO, FL, GA, IA, MA, MI, MO, NE, NY, PA, RI, TX, VA, WI |
| Countries outside the US | CA |
| Quantity | 2,260 units |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2208-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.