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Mazor Robotics Ltd recalls Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renai
Recalled December 26, 2018 · FDA recall Z-0609-2019 · Mazor Robotics
Hazard
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move. · FDA Class II
Units
5 units
Sold at
Affected devices were distributed in the US to four different medical facilities in four states
Description
In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move.
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.
Manufacturer(s)
Mazor Robotics Ltd
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →