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.
FDA Recall Z-0609-2019 · Posted None
Recalling FirmMazor Robotics Ltd
Recall StatusTerminated
Product CodeHAW
Date Initiated2014-11-26
Date Terminated2019-07-03
Product Quantity5 units
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.
Firm Action
All Mazor Brain Clinical Sales Representatives (support during clinical cases) were notified of the issue on 11/26/2014 via email as well as received training.
Root Cause
Device Design
Distribution Pattern
Affected devices were distributed in the US to four different medical facilities in four states
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.