Device recall
Z-2375-2016: Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions…
FDA device recall · Class II · Nobel Biocare Usa Llc
Key facts
| Recall number (Z-number) | Z-2375-2016 |
|---|---|
| Recall event | 74782 |
| Product | Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. The Guided… |
| Product code | DZI |
| Recalling firm | Nobel Biocare Usa Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 17, 2016 |
| 510(k) numbers | K990846 |
| FEI number | 1000125598 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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