Device recall
Z-1822-2011: Ossur Total Knee, Model Number: 2100 The Total Knee 2100 is an external…
FDA device recall · Class II · Ossur Engineering, Inc
Key facts
| Recall number (Z-number) | Z-1822-2011 |
|---|---|
| Recall event | 58002 |
| Product | Ossur Total Knee, Model Number: 2100 The Total Knee 2100 is an external prosthetic knee joint. It is a polycentric knee designed for multi-speed ambulators, higher impact levels and heavier loads. |
| Product code | ISY |
| Recalling firm | Ossur Engineering, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 29, 2012 |
| FEI number | 3002440200 |
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