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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79559

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
January 18, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Neuropro Spinal Jaxx

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1350-2018
Recall number
Z-1350-2018
Initiated
January 18, 2018
Classification
Class II
Status
Terminated
Recalling firm
Neuropro Spinal Jaxx
Quantity
6

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The implant size is incorrectly etched on the implant. The size listed on the box is correct.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Lot 1599, Expiration date: 10/03/2018

Distribution pattern

The devices were distributed in California.