Device recall
Z-0838-2020: Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE…
FDA device recall · Class II · Imactis
Key facts
| Recall number (Z-number) | Z-0838-2020 |
|---|---|
| Recall event | 84460 |
| Product | Imactis Navigation Kit, REF 10100, Content Sterile Needle Holder Ref. A10010 CE 0459, Sensor Cover Ref. PC3688 CE 0482, Adhesif Film Ref. 38.20.15 CE 0459, EN Navigation Kit. Compatible with linear instruments of diameter ranging from 0.5 mm to 3.0 mm (25G to 11G), Sterile, Rx Only, |
| Product code | JAK |
| Recalling firm | Imactis |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K162314 |
| FEI number | 3015060224 |
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