Recall Z-0101-2024— Mazor Robotics Ltd

Name: FDA recall Z-0101-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-05

Class II · Ongoing

Class II FDA medical device recall by Mazor Robotics Ltd, initiated 2023-09-05. It names one FDA 510(k) clearance: K203005. Product: MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.1. Reason: Software update.

Recalling firm: Mazor Robotics Ltd
Classification: Class II
Status: Ongoing
Initiated: 2023-09-05
Firm location: Caesarea, N/A, Israel

510(k) clearances named in this recall

1 on FDA's record

K203005 — Mazor XMazor Robotics , Ltd.·cleared 2020-10-27

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, Model TPL0059, with software versions 4.2.2 or 5.0.1

Reason for recall

Software update

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