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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- Manufacturer
- Neuropro Spinal Jaxx
- Hazard
- 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:
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