Device recall
Z-2261-2015: Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee…
FDA device recall · Class II · Otto Bock Healthcare GmbH
Key facts
| Recall number (Z-number) | Z-2261-2015 |
|---|---|
| Recall event | 71715 |
| Product | Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology. |
| Product code | ISY |
| Recalling firm | Otto Bock Healthcare GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 21, 2017 |
| FEI number | 3003117657 |
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