Device recall
Z-1229-2020: Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B…
FDA device recall · Class II · Taewoong Medical Co., Ltd.
Key facts
| Recall number (Z-number) | Z-1229-2020 |
|---|---|
| Recall event | 84742 |
| Product | Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F |
| Product code | ESW |
| Recalling firm | Taewoong Medical Co., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 15, 2021 |
| 510(k) numbers | K080782, K113551, K123205 |
| FEI number | 3003902943 |
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