Device recall
Z-0655-2019: RT-5100 Refractor, a component of the Epic-5100 System.
FDA device recall · Class III · Nidek Inc.
Key facts
| Recall number (Z-number) | Z-0655-2019 |
|---|---|
| Recall event | 81529 |
| Product | RT-5100 Refractor, a component of the Epic-5100 System. |
| Product code | HKN |
| Recalling firm | Nidek Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 3, 2020 |
| FEI number | 2936921 |
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