Device recall
Z-1960-2015: Spine Wave Access Kit, Catalog Number 10-1530 Package contents…
FDA device recall · Class II · Spine Wave, Inc.
Key facts
| Recall number (Z-number) | Z-1960-2015 |
|---|---|
| Recall event | 71497 |
| Product | Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. Product Usage: The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a… |
| Product code | ETN |
| Recalling firm | Spine Wave, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 24, 2017 |
| 510(k) numbers | K072736 |
| FEI number | 3004638600 |
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