Device recall
Z-0882-2017: Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the…
FDA device recall · Class II · Amendia, Inc
Key facts
| Recall number (Z-number) | Z-0882-2017 |
|---|---|
| Recall event | 75858 |
| Product | Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone |
| Product code | LXH |
| Recalling firm | Amendia, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 1, 2024 |
| FEI number | 3007970248 |
At a glance
- None 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