Spinal FrontiersPowered by NSpineA software fault in the robotic controller may move the arm unexpectedly during bone preparation or instrument positioning; users of the 29 US stations were told to stop using and quarantine them, while the navigation and camera stations can stay in use. Initiated in late July and posted by FDA on 2 September; the station is cleared under a spine navigation and robotic-assistance 510(k).
- Type
- Recall
- Company
- Medos International (Johnson & Johnson MedTech / DePuy Synthes)
- Device
- VELYS Enabling Tech Robotic-Assist Station (REF 451611001)
- Date
- 2 September 2026
- Jurisdiction
- US
- Classification
- FDA Class II recall (Z-3088-2026), initiated 23 Jul 2026, posted 2 Sep 2026; device cleared as spine navigation and robotic assistance (510(k) K233228)
- Source
- FDA Medical Device Recalls database
Read the official notice →Source checked
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