Device recall
Z-0153-2009: Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003 Del Mar…
FDA device recall · Class II · Allez Spine, LLC
Key facts
| Recall number (Z-number) | Z-0153-2009 |
|---|---|
| Recall event | 49444 |
| Product | Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003 Del Mar Pedicle Screw System; IT-ST1001Vertebrae Rotation Tool; IT-H W1001Hex Wrench; IT-CB1001Coronal Bender-L; IT-CB1002 Coronal Bender-R; IT-PH1001Power Rod Holder; IT-BP1001 Thoracic Ball Handle Probe, Curved; IT-BP1002 Thoracic… |
| Product code | MNI |
| Recalling firm | Allez Spine, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 19, 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