Vertebral Motion Analyzer — Class II medical device recall Z-2891-2018
Ongoing recall by Ortho Kinematics, Inc, reported 2018-08-29, distributed nationwide. Ortho Kinematics notified customers that errors were contained in Radiological Read Report and VMA Report for
| Recall number | Z-2891-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Kinematics, Inc, West Lake Hills, TX, United States |
| Recall initiated | 2017-03-02 |
| Classified | 2018-08-22 |
| Reported by FDA | 2018-08-29 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 00868579000209 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2891-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.