Device recall
Z-1670-2009: DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft…
FDA device recall · Class II · DePuy Spine, Inc.
Key facts
| Recall number (Z-number) | Z-1670-2009 |
|---|---|
| Recall event | 51138 |
| Product | DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the… |
| Product code | KWP |
| Recalling firm | DePuy Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 9, 2015 |
| 510(k) numbers | K070300 |
| 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