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U.S. Department of Health and Human Services

Class 2 Device Recall Spinal Jaxx Interbody Fusion Device

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  Class 2 Device Recall Spinal Jaxx Interbody Fusion Device see related information
Date Initiated by Firm January 18, 2018
Create Date April 10, 2018
Recall Status1 Terminated 3 on July 13, 2018
Recall Number Z-1350-2018
Recall Event ID 79559
510(K)Number K152501  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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-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.
Code Information Lot 1599, Expiration date: 10/03/2018
Recalling Firm/
Manufacturer		 Neuropro Spinal Jaxx
6337 Falling Brook Dr
Burke VA 22015-4031
For Additional Information Contact John I. Green
571-334-7424
Manufacturer Reason
for Recall		 The implant size is incorrectly etched on the implant. The size listed on the box is correct.
FDA Determined
Cause 2		 Labeling Change Control
Action The firm called the consignee using a phone script. Additional information requested regarding whether any instructions were provided to the consignee regarding what to do with the recalled devices.
Quantity in Commerce 6
Distribution The devices were distributed in California.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = NEUROPRO SPINAL JAXX, INC.
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