Z-2891-2018Class II

Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254

Name: Z-2891-2018 Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254
Creator: Ortho Kinematics, Inc
Published: 2017-03-02
License: https://open.fda.gov/license/

Wenzel Spine / initiated 2017-03-02 / Open, Classified / root cause: software

FDA source

Ortho Kinematics, Inc began a recall of Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process... on 2017-03-02. FDA classified it as Class II and gives the reason as "Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed". 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-2891-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-03-02
Posted: 2018-08-22
Recalling firm: Wenzel Spine
Product: Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: 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 notified customers that errors were contained in Radiological Read Report and VMA Report for the VMA test. The error resulted from an administrative error of VMA user account settings and has been fixed.
Root cause tag: software
FDA root cause: Software design
Action: Ortho Kinematics notified customers via telephone, email, and letter. Letter dated August 23, 2017 contained the following information: reason for notification, error report information, and requested acknowledgement of receipt.
Quantity in commerce: 1
Distribution: U.S. Nationwide Distribution
Product codes and lots: 00868579000209.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2891-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2891-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-08-29	2018-08-22

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)