Device recall
Z-0095-2014: PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators…
FDA device recall · Class II · DePuy Spine, Inc.
Key facts
| Recall number (Z-number) | Z-0095-2014 |
|---|---|
| Recall event | 65897 |
| Product | PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. |
| Product code | GCC |
| Recalling firm | DePuy Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 29, 2015 |
| FEI number | 1526439 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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