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U.S. Department of Health and Human Services

Class 2 Device Recall THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2

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 Class 2 Device Recall THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2see related information
Date Initiated by FirmMay 23, 2018
Create DateAugust 22, 2018
Recall Status1 Open3, Classified
Recall NumberZ-2889-2018
Recall Event ID 80769
510(K)NumberK133875 
Product Classification System, image processing, radiological - Product Code LLZ
ProductVertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
Code Information 00868579000209
Recalling Firm/
Manufacturer		 Ortho Kinematics, Inc
110 Wild Basin Rd Ste 250
West Lake Hills TX 78746-3352
For Additional Information Contact
512-334-5490
Manufacturer Reason
for Recall		This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.
FDA Determined
Cause 2		Software design
ActionOrtho Kinematics notified customers via Email and notification through web app with a notification dated December 6, 2016. The notification contained the following information: reason for correction, report information, and required action for acknowledgement.
Quantity in Commerce1
DistributionU.S. Nationwide Distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
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