Device recall
Z-0921-2013: 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior…
FDA device recall · Class II · Genesys Orthopedic Systems, LLC
Key facts
| Recall number (Z-number) | Z-0921-2013 |
|---|---|
| Recall event | 64421 |
| Product | 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine. |
| Product code | KWQ |
| Recalling firm | Genesys Orthopedic Systems, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 9, 2013 |
| 510(k) numbers | K111132 |
| FEI number | 3008455034 |
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