Device recall
Z-2916-2016: ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision…
FDA device recall · Class II · New Star Lasers, Inc.
Key facts
| Recall number (Z-number) | Z-2916-2016 |
|---|---|
| Recall event | 75048 |
| Product | ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the great and small saphenous… |
| Product code | GEX |
| Recalling firm | New Star Lasers, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 13, 2016 |
| FEI number | 1000307100 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database