Device recall
Z-0624-2017: DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW…
FDA device recall · Class II · DePuy Spine, Inc.
Key facts
| Recall number (Z-number) | Z-0624-2017 |
|---|---|
| Recall event | 75454 |
| Product | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of… |
| Product code | KWQ |
| Recalling firm | DePuy Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 18, 2017 |
| 510(k) numbers | K052552 |
| FEI number | 1526439 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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