CLASS II ONGOING Device recall · Reported 29 Aug 2018 · FDA Enforcement Report
Vertebral Motion Analyzer (VMA), VMA DataLink recalled
Ortho Kinematics is recalling Vertebral Motion Analyzer (VMA), VMA DataLink, distributed nationwide in the US. The recall was initiated on 12 Aug 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2890-2018
- FDA event ID
- 80768
- Recalling firm
- Ortho Kinematics, West Lake Hills, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Aug 2016
- FDA classified
- 22 Aug 2018
- Reported
- 29 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 12 Aug 2016 | Recall initiated by company | |
| 22 Aug 2018 | Classified by FDA | +740 days |
| 29 Aug 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide Distribution
Questions about this recall
Is Vertebral Motion Analyzer (VMA), VMA DataLink recalled?
Yes. Ortho Kinematics recalled Vertebral Motion Analyzer (VMA), VMA DataLink on 12 Aug 2016. The recall is Class II and its status is Ongoing. Recall number Z-2890-2018.
Why was it recalled?
Ortho Kinematics, Inc. notified customers of erroneous results of VMA tests due to a software bug that has been corrected.
Which lots are affected?
00868579000209
Where was it sold?
U.S. Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ortho Kinematics
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Vertebral Motion Analyzer (VMA) recalled by Ortho Kinematics | Ortho Kinematics | Device Malfunction | Nationwide |
| Device | CLASS II | Vertebral Motion Analyzer (VMA) recalled by Ortho Kinematics | Ortho Kinematics | Device Malfunction | Nationwide |
| Device | CLASS II | Vertebral Motion Analyzer (VMA) recalled by Ortho Kinematics | Ortho Kinematics | Device Malfunction | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |