Device recall
Z-1765-2008: X-STOP Interspinous Process Decompression (lPD) System, (With Physician's Guide…
FDA device recall · Class II · Kyphon Inc
Key facts
| Recall number (Z-number) | Z-1765-2008 |
|---|---|
| Recall event | 47490 |
| Product | X-STOP Interspinous Process Decompression (lPD) System, (With Physician's Guide, P/N 16000789-01 (Ti device), P/N 16001013-01 (PEEK device); Catalog numbers for X-STOP Titanium Implant: 1-2206 US 6MM X-STOP, 1-2208 US 8MM X-STOP, 1-2210 US 10MM X-STOP, 1-2212 US 12MM X-STOP, 1-2214 US 14MM X-STOP… |
| Product code | NQO |
| Recalling firm | Kyphon Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 14, 2009 |
| PMA numbers | P040001 |
| FEI number | 3004904811 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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