Device recall
Z-1309-2020: Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills…
FDA device recall · Class II · Nobel Biocare Usa Llc
Key facts
| Recall number (Z-number) | Z-1309-2020 |
|---|---|
| Recall event | 84450 |
| Product | Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants. |
| 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