Device recall
Z-1512-2017: Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample…
FDA device recall · Class II · Devicor Medical Products Inc
Key facts
| Recall number (Z-number) | Z-1512-2017 |
|---|---|
| Recall event | 76603 |
| Product | Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance |
| Product code | KNW |
| Recalling firm | Devicor Medical Products Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 3, 2017 |
| 510(k) numbers | K152989 |
| FEI number | 3008492462 |
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