Device recall
Z-0643-2019: Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic…
FDA device recall · Class II · Theragenics Corporation
Key facts
| Recall number (Z-number) | Z-0643-2019 |
|---|---|
| Recall event | 81537 |
| Product | Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle. |
| Product code | IWJ |
| Recalling firm | Theragenics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 18, 2020 |
| FEI number | 1037598 |
At a glance
- None 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