Device recall
Z-3175-2011: Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo…
FDA device recall · Class II · Medtronic Spine LLC (formerly Kyphon Inc.)
Key facts
| Recall number (Z-number) | Z-3175-2011 |
|---|---|
| Recall event | 58425 |
| Product | Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC (formerly known as Kyphon Inc), Sunnyvale, CA Designed to reduce kyphosis that results from vertebral body collapse due… |
| Product code | HRX |
| Recalling firm | Medtronic Spine LLC (formerly Kyphon Inc.) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 9, 2011 |
| 510(k) numbers | K011811 |
| FEI number | 3004904811 |
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