Device recall
Z-1324-2015: Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by…
FDA device recall · Class II · TITAN SPINE, LLC
Key facts
| Recall number (Z-number) | Z-1324-2015 |
|---|---|
| Recall event | 70576 |
| Product | Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD). |
| Product code | OVE |
| Recalling firm | TITAN SPINE, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2015 |
| 510(k) numbers | K142940 |
| FEI number | 3006340236 |
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