Device recall
Z-0932-2012: Solanas Posterior Stabilization System Part Number: 63920. Solanas Posterior…
FDA device recall · Class II · Alphatec Spine, Inc.
Key facts
| Recall number (Z-number) | Z-0932-2012 |
|---|---|
| Recall event | 59920 |
| Product | Solanas Posterior Stabilization System Part Number: 63920. Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Solanas Posterior… |
| Product code | KWP |
| Recalling firm | Alphatec Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 31, 2012 |
| 510(k) numbers | K052201, K071380 |
| FEI number | 2027467 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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