Device recall
Z-2211-2016: Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 &…
FDA device recall · Class II · Devicor Medical Products Inc
Key facts
| Recall number (Z-number) | Z-2211-2016 |
|---|---|
| Recall event | 74297 |
| Product | Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date… |
| Product code | OIJ |
| Recalling firm | Devicor Medical Products Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 3, 2017 |
| 510(k) numbers | K123259 |
| FEI number | 3008492462 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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