Device recall
Z-1545-2012: Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate…
FDA device recall · Class II · Captiva Spine, Inc
Key facts
| Recall number (Z-number) | Z-1545-2012 |
|---|---|
| Recall event | 61804 |
| Product | Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical Plate System components are supplied clean and not sterile. All implants and instruments should be cleaned and sterilized prior to surgery. AORN recommended practices for in… |
| 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