Device recall
Z-0405-2019: FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System)…
FDA device recall · Class II · Integrity Implants Inc.
Key facts
| Recall number (Z-number) | Z-0405-2019 |
|---|---|
| Recall event | 81247 |
| Product | FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease. |
| Product code | MAX |
| Recalling firm | Integrity Implants Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 6, 2019 |
| 510(k) numbers | K160076 |
| FEI number | 3012797630 |
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