Device recall
Z-1478-2017: Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the…
FDA device recall · Class II · Inion Ltd.
Key facts
| Recall number (Z-number) | Z-1478-2017 |
|---|---|
| Recall event | 76638 |
| Product | Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for covering bone defects and… |
| Product code | NPK |
| Recalling firm | Inion Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 18, 2017 |
| 510(k) numbers | K033074 |
| FEI number | 3003407235 |
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