Vertebral Motion Analyzer (VMA), VMA DataLink… recallZ-2890-2018 · Ortho Kinematics, Inc · initiated Aug 12, 2016
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, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.
FDA root cause category: Software design
What the company is doing
Ortho Kinematics, Inc. notified customers via email dated August 19, 2016, Notice of Correction to VMA Results. The notification included the following information: reason for notice of correction, error information, and required action of acknowledgement.
Recall details
- Recall number
- Z-2890-2018
- Status
- Open, Classified
- Initiated by the company
- Aug 12, 2016
- Recalling firm
- Ortho Kinematics, Inc
- Quantity
- 1
- Product code
- LLZ
- FDA submissions
- K133875
- Distribution
- U.S. Nationwide Distribution
Product description
Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. 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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