Device recall
Z-0960-2013: DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery…
FDA device recall · Class II · DePuy Spine, Inc.
Key facts
| Recall number (Z-number) | Z-0960-2013 |
|---|---|
| Recall event | 64072 |
| Product | DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. |
| Product code | NDN |
| Recalling firm | DePuy Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2014 |
| 510(k) numbers | K060300 |
| FEI number | 1526439 |
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