The Recall Desk
LowFDA (Devices)·Z-1350-2018·Announced 2018-04-18

Neuropro Spinal Jaxx Interbody Fusion Device Recall for Incorrect Size Etching

Neuropro Spinal Jaxx is recalling six Spinal Jaxx Interbody Fusion Devices because the implant size is incorrectly etched on the device, although the box label is correct.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a cosmetic or documentation defect (incorrect etching) where the packaging label is correct, fitting the criteria for Low severity.

Plain-English summary

Neuropro Spinal Jaxx is recalling six units of the Spinal Jaxx Interbody Fusion Device, Model 100001-511, Size 9 H x 10 W x 25 L. The recall is due to a labeling error where the implant size is incorrectly etched on the physical implant, while the size listed on the packaging box is correct.

The affected devices are from Lot 1599 with an expiration date of 10/03/2018. These devices were distributed in California. The Spinal Jaxx interbody fusion device is indicated for spinal fusion in patients with degenerative disc disease at one or two contiguous levels of the lumbosacral spine.

Healthcare providers and patients should contact Neuropro Spinal Jaxx for further instructions regarding the return or replacement of these specific units.

The recalled product

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
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot 1599
  • Expiration date: 10/03/2018

Distribution

Distributed in 1 state: