Device recall
Z-1315-2020: Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to…
FDA device recall · Class II · Nobel Biocare Usa Llc
Key facts
| Recall number (Z-number) | Z-1315-2020 |
|---|---|
| Recall event | 84450 |
| Product | Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. |
| Product code | DZI |
| Recalling firm | Nobel Biocare Usa Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 15, 2024 |
| 510(k) numbers | K990846 |
| FEI number | 1000125598 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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