Spinal Jaxx Interbody Fusion Device — Class II medical device recall Z-1350-2018
Terminated recall by Neuropro Spinal Jaxx, reported 2018-04-18, distributed in CA. The implant size is incorrectly etched on the implant. The size listed on the box is correct.
| Recall number | Z-1350-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neuropro Spinal Jaxx, Burke, VA, United States |
| Recall initiated | 2018-01-18 |
| Classified | 2018-04-10 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2018-07-13 |
| Distributed | CA |
| Quantity | 6 |
| Lot numbers | 1599 |
| Model numbers | 100001-511 |
| Expiration dates | 2018-10-03 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1350-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.