Device recall
Z-1350-2018: Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L…
FDA device recall · Class II · Neuropro Spinal Jaxx
Key facts
| Recall number (Z-number) | Z-1350-2018 |
|---|---|
| Recall event | 79559 |
| Product | Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as… |
| Product code | MAX |
| Recalling firm | Neuropro Spinal Jaxx |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2018 |
| 510(k) numbers | K152501 |
| FEI number | 3013378904 |
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