# FDA recall Z-1350-2018

> **Neuropro Spinal Jaxx** · Class II · device recall initiated 2018-01-18.

## 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 for recall

The implant size is incorrectly etched on the implant. The size listed on the box is correct.

## Distribution

The devices were distributed in California.

## Key facts

- **Recall number:** Z-1350-2018
- **Recalling firm:** Neuropro Spinal Jaxx
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-18
- **Report date:** 2018-04-18
- **Termination date:** 2018-07-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Burke, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1350-2018

## Citation

> AI Analytics. FDA recall Z-1350-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1350-2018. Source: US FDA. Licensed CC0.

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