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Neuropro Spinal Jaxx recalls Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx inter
Recalled April 18, 2018 · FDA recall Z-1350-2018 · Neuropro Spinal Jaxx
Hazard
The implant size is incorrectly etched on the implant. The size listed on the box is correct. · FDA Class II
Units
6
Sold at
The devices were distributed in California.
Description
The implant size is incorrectly etched on the implant. The size listed on the box is correct.
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.
Manufacturer(s)
Neuropro Spinal Jaxx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →