Recall Z-1122-2026— Mazor Robotics Ltd

Name: FDA recall Z-1122-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-10

Class II · Ongoing

Class II FDA medical device recall by Mazor Robotics Ltd, initiated 2025-12-10. It names one FDA 510(k) clearance: K230064. Product: Mazor X robotic guidance system REF: TPL0059. Reason: Software errors that can result in incorrect surgical instrument positioning during spinal surgery..

Recalling firm: Mazor Robotics Ltd
Classification: Class II
Status: Ongoing
Initiated: 2025-12-10
Firm location: Caesarea, Israel

510(k) clearances named in this recall

1 on FDA's record

K230064 — Mazor X System (Mazor X Stealth Edition)Mazor Robotics , Ltd.·cleared 2023-04-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Mazor X robotic guidance system REF: TPL0059

Reason for recall

Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

Data sourced from openFDA. This site is unofficial and independent of the FDA.