Z-1350-2018Class II

Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L

Name: Z-1350-2018 Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L
Creator: Neuropro Spinal Jaxx
Published: 2018-01-18
License: https://open.fda.gov/license/

Neuropro Spinal Jaxx / initiated 2018-01-18 / Terminated / root cause: labeling and UDI

FDA source

Neuropro Spinal Jaxx began a recall of 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... on 2018-01-18. FDA classified it as Class II and gives the reason as "The implant size is incorrectly etched on the implant. The size listed on the box is correct". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1350-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-18
Posted: 2018-04-10
Terminated: 2018-07-13
Recalling firm: Neuropro Spinal Jaxx
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.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: The implant size is incorrectly etched on the implant. The size listed on the box is correct.
Root cause tag: labeling and UDI
FDA 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 in commerce: 6
Distribution: The devices were distributed in California.
Product codes and lots: Lot 1599, Expiration date: 10/03/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1350-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1350-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10

Product code MAX

K152501Class IISpinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc. / cleared 2016-06-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)