Device recall
Z-0895-2013: Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic…
FDA device recall · Class II · Orthofix, Inc
Key facts
| Recall number (Z-number) | Z-0895-2013 |
|---|---|
| Recall event | 62804 |
| Product | Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur. |
| Product code | HSB |
| Recalling firm | Orthofix, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2013 |
| 510(k) numbers | K010322, K031219 |
| FEI number | 2183449 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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