Data Foundry

Medical device recalls 2018

Vertebral Motion Analyzer — Class II medical device recall Z-2890-2018

Ongoing recall by Ortho Kinematics, Inc, reported 2018-08-29, distributed nationwide. Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has bee

Recall numberZ-2890-2018
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmOrtho Kinematics, Inc, West Lake Hills, TX, United States
Recall initiated2016-08-12
Classified2018-08-22
Reported by FDA2018-08-29
DistributedNationwide (US)
Quantity1
Reason classessoftware
UPC / GTIN / UDI-DI00868579000209

Product

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.

Reason for recall

Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.

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-2890-2018. 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.