Device recall
Z-2327-2015: Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the…
FDA device recall · Class II · TITAN SPINE, LLC
Key facts
| Recall number (Z-number) | Z-2327-2015 |
|---|---|
| Recall event | 71740 |
| Product | Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locking Screws; 5302-3516 / 03.5 x 16mm Locking Screws; 502-3518 / 03.5 x 18mm Locking Screws; 5302-3814 /… |
| Product code | OVE |
| Recalling firm | TITAN SPINE, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 20, 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