Neuropro Spinal Jaxx: Medical Device Recall in 2018 - (Recall #: Z-1350-2018)
See the recall detail below. You can also see other recalls from the same firm in 2018.
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.
Class II
The implant size is incorrectly etched on the implant. The size listed on the box is correct.
Lot 1599, Expiration date: 10/03/2018
The devices were distributed in California.
Voluntary: Firm initiated