Device recall
Z-1937-2012: Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement…
FDA device recall · Class II · DePuy Mitek, Inc., a Johnson & Johnson Co.
Key facts
| Recall number (Z-number) | Z-1937-2012 |
|---|---|
| Recall event | 61874 |
| Product | Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. |
| Product code | OAR |
| Recalling firm | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2016 |
| FEI number | 1221934 |
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