Device recall
Z-0657-2020: Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
FDA device recall · Class II · Medtronic Navigation, Inc.
Key facts
| Recall number (Z-number) | Z-0657-2020 |
|---|---|
| Recall event | 84191 |
| Product | Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 |
| Product code | HAW |
| Recalling firm | Medtronic Navigation, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K971247 |
| FEI number | 1000517638 |
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