Reported Apr 18, 2018 · Terminated
Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx…
Neuropro Spinal Jaxx
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Neuropro Spinal Jaxx · 6337 Falling Brook Dr · Burke, VA · 22015-4031
Is this the product you have?
- Spinal Jaxx Interbody Fusion Device
- Model100001-511
- Size9
- H x 10 W x 25 L Product UsageThe 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
- Lot codes and dates
- Lot 1599
- Expiration date10/03/2018
- Amount recalled
- 6
Where it was sold
Why it was recalled
The implant size is incorrectly etched on the implant. The size listed on the box is correct.
This product could cause temporary or reversible health problems — stop using it.
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