Device recall
Z-1909-2011: SPIDER Surgical Platform The SPIDER is a single port, single incision device to…
FDA device recall · Class II · Transenterix, Inc
Key facts
| Recall number (Z-number) | Z-1909-2011 |
|---|---|
| Recall event | 58093 |
| Product | SPIDER Surgical Platform The SPIDER is a single port, single incision device to facilitate multi-instrument access during laparoscopic surgical procedures. The SPIDER device is provided pre-sterilized and is a single use device. |
| Product code | GCJ |
| Recalling firm | Transenterix, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 7, 2011 |
| 510(k) numbers | K090902 |
| FEI number | 3007593944 |
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