Device recall
Z-0363-2007: Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used…
FDA device recall · Class II · Bock,Otto,Orthopedic Ind,Inc
Key facts
| Recall number (Z-number) | Z-0363-2007 |
|---|---|
| Recall event | 36256 |
| Product | Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees. |
| Product code | KFX |
| Recalling firm | Bock,Otto,Orthopedic Ind,Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 26, 2008 |
| 510(k) numbers | K991590 |
| FEI number | 2182293 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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