Device recall
Z-2258-2013: VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint…
FDA device recall · Class II · Spine Smith Holdings, LLC
Key facts
| Recall number (Z-number) | Z-2258-2013 |
|---|---|
| Recall event | 65999 |
| Product | VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach. |
| Product code | MAX |
| Recalling firm | Spine Smith Holdings, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 18, 2014 |
| 510(k) numbers | K102090 |
| FEI number | 3010266937 |
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