Device recall
Z-2118-2020: Clearview Total Uterine Manipulator (model UM750), The device is labeled in…
FDA device recall · Class II · Clinical Innovations, LLC
Key facts
| Recall number (Z-number) | Z-2118-2020 |
|---|---|
| Recall event | 85144 |
| Product | Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufacturer: Clinical Innovations, LLC* * *Reorder Number: UM750* * *LOT 181183* * *." Each device is accompanied by Instruction for Use which is similarly labeled. |
| Product code | LKF |
| Recalling firm | Clinical Innovations, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2020 |
| 510(k) numbers | K131781 |
| FEI number | 1000220650 |
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