Device recall
Z-1819-2008: Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray #…
FDA device recall · Class II · Allez Spine, LLC
Key facts
| Recall number (Z-number) | Z-1819-2008 |
|---|---|
| Recall event | 48116 |
| Product | Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part Number: 54003); IT-FN1002, Laguna Sterilization Tray # 2 (Part Number: 54004) |
| Product code | MNI |
| Recalling firm | Allez Spine, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 25, 2010 |
| 510(k) numbers | K050060 |
| 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