Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254 recallZ-2891-2018 · Ortho Kinematics, Inc · initiated Mar 2, 2017
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ortho Kinematics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-2891-2018
- Status
- Open, Classified
- Initiated by the company
- Mar 2, 2017
- Recalling firm
- Ortho Kinematics, Inc
- Quantity
- 1
- Product code
- LLZ
- FDA submissions
- K133875
- Distribution
- U.S. Nationwide Distribution
Product description
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.
Code information (models, lots, serial numbers)
00868579000209.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VMA 2Ortho Kinematics, Inc. · System, Image Processing, Radiological4 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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