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.
FDA Recall Z-1350-2018 · Posted None
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Recalling FirmNeuropro Spinal Jaxx
Recall StatusTerminated
Product CodeMAX
Date Initiated2018-01-18
Date Terminated2018-07-13
Product Quantity6
Reason for Recall
The implant size is incorrectly etched on the implant. The size listed on the box is correct.
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
The devices were distributed in California.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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