Device recall
Z-1200-06: Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee.
FDA device recall · Class II · Ossur North America Inc
Key facts
| Recall number (Z-number) | Z-1200-06 |
|---|---|
| Recall event | 35132 |
| Product | Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee. |
| Product code | ISY |
| Recalling firm | Ossur North America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2008 |
| FEI number | 1000519909 |
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