Device recall
Z-0146-04: KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A…
FDA device recall · Class II · Kyphon Inc
Key facts
| Recall number (Z-number) | Z-0146-04 |
|---|---|
| Recall event | 27597 |
| Product | KyphX Xpander brand Inflation Syringe; Merit Medical Part Number: K05-01290A. Kyphon Catalog Number: A08A. The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation Syringe. This medical device is provided as an individual stand-alone package (which also contains an… |
| Product code | DXT |
| Recalling firm | Kyphon Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2004 |
| 510(k) numbers | K011811 |
| FEI number | 3004904811 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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