Device recall
Z-1134-2017: Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm…
FDA device recall · Class II · Medtronic Advanced Energy, LLC
Key facts
| Recall number (Z-number) | Z-1134-2017 |
|---|---|
| Recall event | 76130 |
| Product | Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for… |
| Product code | KNW |
| Recalling firm | Medtronic Advanced Energy, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 11, 2017 |
| 510(k) numbers | K003190 |
| FEI number | 1000517638 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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