Vertebral Motion Analyzer (VMA), 2.3.250 recallZ-2889-2018 · Ortho Kinematics, Inc · initiated May 23, 2018
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
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 root cause category: Software design
What the company is doing
Ortho 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.
Recall details
- Recall number
- Z-2889-2018
- Status
- Open, Classified
- Initiated by the company
- May 23, 2018
- Recalling firm
- Ortho Kinematics, Inc
- Quantity
- 1
- Product code
- LLZ
- FDA submissions
- K133875
- Distribution
- U.S. Nationwide Distribution
Product description
Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
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.
How recalls are matched to devices · Editorial policy · Report an error on this page