Device recall
Z-1445-2008: QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-1445-2008 |
|---|---|
| Recall event | 47244 |
| Product | QWIX Screw 4.3mm diam; length 26 mm; The stabilization screw is indicated for fixation of bone fractures or for bone reconstruction. |
| Product code | HWC |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 21, 2008 |
| 510(k) numbers | K050346 |
| FEI number | 3003418325 |
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