Device recall
Z-1118-2015: HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use…
FDA device recall · Class II · Intuitive Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-1118-2015 |
|---|---|
| Recall event | 70275 |
| Product | HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System |
| Product code | NAY |
| Recalling firm | Intuitive Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 1, 2015 |
| 510(k) numbers | K093217 |
| FEI number | 3001675293 |
At a glance
- 1–9 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