Device recall
Z-1172-2012: K3 Engine File G-Pack, Product: Endodontic Pulp Canal File, Part Number…
FDA device recall · Class III · Ormco Corporation
Key facts
| Recall number (Z-number) | Z-1172-2012 |
|---|---|
| Recall event | 61224 |
| Product | K3 Engine File G-Pack, Product: Endodontic Pulp Canal File, Part Number: 830-9925. For use in root canal preparation. |
| Product code | EKS |
| Recalling firm | Ormco Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 8, 2012 |
| FEI number | 2016150 |
At a glance
- None 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