Recall Z-1350-2018— Neuropro Spinal Jaxx
Class II · Terminated
Class II FDA medical device recall by Neuropro Spinal Jaxx, initiated 2018-01-18, terminated 2018-07-13. It names one FDA 510(k) clearance: K152501. 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 discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.. Reason: The implant size is incorrectly etched on the implant. The size listed on the box is correct..
- Recalling firm
- Neuropro Spinal Jaxx
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-18
- Terminated
- 2018-07-13
- Firm location
- Burke, VA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.
Reason for recall
The implant size is incorrectly etched on the implant. The size listed on the box is correct.
Data sourced from openFDA. This site is unofficial and independent of the FDA.