Device recall
Z-0262-2010: Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb…
FDA device recall · Class II · Orthofix, Inc
Key facts
| Recall number (Z-number) | Z-0262-2010 |
|---|---|
| Recall event | 53578 |
| Product | Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device consisting of a telescoping Internal Limb Lengthener, Locking Screws, Instrumentation and an external hand-held Monitor; catalog numbers: T10-215-265, T10-215-265NS, T10-255-305, T10-255-305NS, T10-255-335… |
| Product code | HSB |
| Recalling firm | Orthofix, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 24, 2010 |
| FEI number | 2183449 |
At a glance
- None 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