Chrysalis Intelligence · Sponsors · Mazor Robotics , Ltd.

Mazor Robotics , Ltd.

Caeasarea, IL · 4 510(k) clearances · 3 recalls

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Total clearances
4
2020-05-08 → 2025-09-11
Last 12 months
1
Product codes
1
Most recent
2025-09-11
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OLO Orthopedic Stereotaxic Instrument Class II Neurology 4 2025-09-11
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
3
Most recent
2025-12-10
DateSeverityStatusRecall # ProductCodeReason
2025-12-10 Class II Ongoing Z-1122-2026 Mazor X robotic guidance system REF: TPL0059 — Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
2024-07-17 Class II Ongoing Z-3156-2024 Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument — Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the n…
2023-09-05 Class II Ongoing Z-0101-2024 MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1 — Software update
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2025-09-11 K251316 Mazor X System / Mazor X Stealth Edition OLO Class II Neurology
2023-04-07 K230064 Mazor X System (Mazor X Stealth Edition) OLO Class II Neurology
2020-10-27 K203005 Mazor X OLO Class II Neurology
2020-05-08 K200935 Mazor X OLO Class II Neurology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence