Device recall
Z-0154-2009: Allez Spine Del Mar Pedicle Screw System; Catalog Number: IT-FN1001 Laguna…
FDA device recall · Class II · Allez Spine, LLC
Key facts
| Recall number (Z-number) | Z-0154-2009 |
|---|---|
| Recall event | 49444 |
| Product | Allez Spine Del Mar Pedicle Screw System; Catalog Number: IT-FN1001 Laguna Pedicle Screw System Tray #1; IT-FN 1002 Laguna Pedicle Screw System Tray #2; lT-CT1001Counter Torque (w/Large Rubber Handle); IT-HP1001 Head Positioner (w/Rubber Handle); IT-RP1001Rod Pusher; lT-RK1001 Rocker (Goal Post… |
| Product code | NKB |
| Recalling firm | Allez Spine, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 19, 2010 |
| 510(k) numbers | K051275 |
| FEI number | 3005032381 |
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