FDAClass IIApril 18, 2018

Spinal Jaxx Interbody Fusion Device recall

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…

Why was Spinal Jaxx Interbody Fusion Device recalled?

The implant size is incorrectly etched on the implant. The size listed on the box is correct.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 1599, Expiration date: 10/03/2018

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…
Recalling firm
Neuropro Spinal Jaxx
Quantity
6
Distribution
The devices were distributed in California.
Recall date
April 18, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls