Recall Z-1350-2018 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Neuropro Spinal Jaxx
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 discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. P
| Date | Jan 18, 2018 |
| Status | Terminated |
| Reason | The implant size is incorrectly etched on the implant. The size listed on the box is correct. |
| Root cause | Labeling Change Control |
| Action | The firm called the consignee using a phone script. Additional information requested regarding whether any instructions were provided to the consignee regarding what to do with the recalled devices. |
| Quantity | 6 |
| Distribution | The devices were distributed in California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152501 | Spinal Jaxx Interbody Fusion Device Neuropro Spinaljaxx, Inc., Jun 29, 2016 |