Device recall
Z-1819-2013: Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx…
FDA device recall · Class II · Custom Spine, Inc.
Key facts
| Recall number (Z-number) | Z-1819-2013 |
|---|---|
| Recall event | 65068 |
| Product | Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to… |
| Product code | NKB |
| Recalling firm | Custom Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 24, 2013 |
| 510(k) numbers | K070281, K072866, K111099 |
| FEI number | 3005129649 |
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