Silhouette Lift
Sinclair Pharma US Inc. · Model SMS 06-PP-3.0.1-B-L · UDI-DI 05060033040232
Description
Silhouette Lift suture is a non-absorbable polypropylene suture with an implantable grade L-lactide/Glycolide (PLG-8218) resorbable based cone that has been injection molded to strict tolerances and affixed to the polypropylene base suture in a secondary operation without any modification or degradation to the base suture. This model number of Silhouette Lift suture is 40.5 cm in length, with a total of 6 molded cones fixed to the distal end of the suture along with a blunt needle. Silhouette Lift suture is indicated for use in mid-face suspension surgery to fixate the cheek dermis in an elevated position.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-24 | Covidien, LP | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v |
| 2026-06-24 | Covidien, LP | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v |
| 2024-09-25 | Ethicon, Inc. | Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the pack |
| 2024-05-10 | Ethicon, Inc. | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| 2024-05-10 | Ethicon, Inc. | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| 2024-05-10 | Ethicon, Inc. | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| 2024-05-10 | Ethicon, Inc. | Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection . |
| 2024-03-26 | SURGICAL SPECIALTIES | Complaints have been received with allegations of Incorrect Needle Curvature. |
| 2024-03-08 | Ethicon, Inc. | Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility |
| 2022-09-28 | Covidien, LP | Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the ne |
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