Device recall
Z-0812-2015: ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic…
FDA device recall · Class II · 4-Web Inc.
Key facts
| Recall number (Z-number) | Z-0812-2015 |
|---|---|
| Recall event | 69662 |
| Product | ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height |
| Product code | MAX |
| Recalling firm | 4-Web Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 27, 2016 |
| 510(k) numbers | K112316 |
| FEI number | 3009189869 |
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