Device recall
Z-0507-2018: The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew…
FDA device recall · Class II · Microline Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-0507-2018 |
|---|---|
| Recall event | 78754 |
| Product | The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures. |
| Product code | GEI |
| Recalling firm | Microline Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 6, 2020 |
| 510(k) numbers | K962119, K974066 |
| FEI number | 1000137656 |
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