Recall Z-0609-2019— Mazor Robotics Ltd

Name: FDA recall Z-0609-2019
Creator: U.S. Food and Drug Administration
Published: 2014-11-26

Class II · Terminated

Class II FDA medical device recall by Mazor Robotics Ltd, initiated 2014-11-26, terminated 2019-07-03. It names one FDA 510(k) clearance: K120812. Product: Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.. Reason: In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move..

Recalling firm: Mazor Robotics Ltd
Classification: Class II
Status: Terminated
Initiated: 2014-11-26
Terminated: 2019-07-03
Firm location: North Industrial Park, Israel

510(k) clearances named in this recall

1 on FDA's record

K120812 — RENAISSANCEMazor Robotics , Ltd.·cleared 2012-07-12

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

Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of, high contrast objects.

Reason for recall

In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.

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