Device recall
Z-2706-2020: Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM)…
FDA device recall · Class II · Richard Wolf GmbH
Key facts
| Recall number (Z-number) | Z-2706-2020 |
|---|---|
| Recall event | 85863 |
| Product | Tube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination system and the instrument set for the TEM procedure are designed to provide access to the rectal cavity and accessible part of the lower sigmoid colon using a stereo and/or monocular endoscope under gas tight… |
| Product code | HIF |
| Recalling firm | Richard Wolf GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 28, 2024 |
| 510(k) numbers | K000180 |
| FEI number | 3002808001 |
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