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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 Devicesee related information
Date Initiated by FirmJanuary 18, 2018
Create DateApril 10, 2018
Recall Status1 Terminated 3 on July 13, 2018
Recall NumberZ-1350-2018
Recall Event ID 79559
510(K)NumberK152501 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductSpinal 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 ContactJohn 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
ActionThe 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 Commerce6
DistributionThe devices were distributed in California.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MAX
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