Device recall
Z-0826-2019: 21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively…
FDA device recall · Class II · Ottobock Orthopedic Industrie
Key facts
| Recall number (Z-number) | Z-0826-2019 |
|---|---|
| Recall event | 81926 |
| Product | 21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket. |
| Product code | ISY |
| Recalling firm | Ottobock Orthopedic Industrie |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 22, 2021 |
| FEI number | 3004024451 |
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