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NextAR™ Spine
Medacta International SA · Model 03.57.10.0248 · UDI-DI 07630542741685
1
510(k) clearances
4
Adverse events
2
Recalls
36
Facilities
Description
NextAR Spine S2AI Screwdriver T20 Inner Shaft
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-13 | Kico Knee Innovation Company | Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing |
| 2025-09-19 | Kico Knee Innovation Company | Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.