Device recall
Z-2347-2008: KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in…
FDA device recall · Class II · Kyphon Inc
Key facts
| Recall number (Z-number) | Z-2347-2008 |
|---|---|
| Recall event | 48988 |
| Product | KyphX Osteo Introducer System with blunt tip introducer stylet (as contained in the KyphoPak Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by Medtronic Spine LLC. Device is used to access vertebral body during balloon kyphoplasty, a procedure designed to reduce and… |
| Product code | LXH |
| Recalling firm | Kyphon Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 7, 2009 |
| FEI number | 3004904811 |
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