Device recall
Z-0410-2014: Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA…
FDA device recall · Class II · Synthes USA HQ, Inc.
Key facts
| Recall number (Z-number) | Z-0410-2014 |
|---|---|
| Recall event | 66414 |
| Product | Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure. |
| Product code | OAR |
| Recalling firm | Synthes USA HQ, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 16, 2015 |
| FEI number | 3005180112 |
At a glance
- None 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