Aug

2018

Recall – Vertebral Motion Analyzer

Company: Ortho Kinematics, Inc
Date of Enforcement Report 8/29/2018
Class II:

PRODUCT
Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files. Recall Number: Z-2882-2018

REASON
Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. The error occurred due to a software bug that has been corrected.

RECALLING FIRM/MANUFACTURER
Ortho Kinematics, Inc, West Lake Hills, TX on 1/11/2017 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1

DISTRIBUTION
Nationwide

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