Device recall
Z-1648-2012: Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are…
FDA device recall · Class II · Captiva Spine, Inc
Key facts
| Recall number (Z-number) | Z-1648-2012 |
|---|---|
| Recall event | 61811 |
| Product | Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" The Captiva Spine SmartLOX Cervical Plate System is intended for the… |
| Product code | KWQ |
| Recalling firm | Captiva Spine, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 18, 2013 |
| 510(k) numbers | K073708 |
| FEI number | 3006082533 |
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