Device recall
Z-1919-2009: Malibu Polyaxial Screw, 6.5 x 35mm Part Number 12-6535 Malibu Spinal System when…
FDA device recall · Class II · SeaSpine, Inc
Key facts
| Recall number (Z-number) | Z-1919-2009 |
|---|---|
| Recall event | 52115 |
| Product | Malibu Polyaxial Screw, 6.5 x 35mm Part Number 12-6535 Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and… |
| Product code | KWP |
| Recalling firm | SeaSpine, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2011 |
| 510(k) numbers | K051942 |
| FEI number | 3003790069 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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