Z-2882-2018Class II

Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application...

Name: Z-2882-2018 Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application...
Creator: Ortho Kinematics, Inc
Published: 2017-01-11
License: https://open.fda.gov/license/

Wenzel Spine / initiated 2017-01-11 / Open, Classified / root cause: software

FDA source

Ortho Kinematics, Inc began a recall of 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 on 2017-01-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2882-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-01-11
Posted: 2018-08-21
Recalling firm: Wenzel Spine
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Ortho Kinematics Inc sent notification to customers on 1/11/2017 via Letter and electronic notification through web app. The company deployed a software upgrade (VMA version 2.3.253) on January 11, 2017.
Quantity in commerce: 1
Distribution: US Nationwide Distribution
Product codes and lots: UDI: 00868579000209

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2882-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2882-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-08-29	2018-08-21

Product code LLZ

K133875Class IIThe Kinegraph Vma (Vertebral Motion Analyzer) Software Version 2.2, the Motion Normalizer Patient Handling and DataOrtho Kinematics, Inc. / cleared 2014-01-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)