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U.S. Department of Health and Human Services

Class 2 Device Recall Carousel MAS102501, part of the Brain Surgical Accessories Intraoperative Kit (KIT0295)

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 Class 2 Device Recall Carousel MAS102501, part of the Brain Surgical Accessories Intraoperative Kit (KIT0295)see related information
Date Initiated by FirmNovember 26, 2014
Create DateDecember 14, 2018
Recall Status1 Terminated 3 on July 03, 2019
Recall NumberZ-0609-2019
Recall Event ID 81521
510(K)NumberK120812 
Product Classification Neurological Stereotaxic Instrument - Product Code HAW
ProductCarousel 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.
Code Information Affected products: all Carousels under Level 01 were affected and therefore are applicable to this issue.   The related lots include: WP065611, WP066389, WP066411, WP066412, WP066420.   Explanation of the coding system: a part number (e.g. MAS1025-01) is composed of a generic part number related to the part (e.g. MAS1025) and the level of the part (e.g. 01).
Recalling Firm/
Manufacturer		 Mazor Robotics Ltd
5 Shacham Street
P.O. Box 3104
North Industrial Park Israel
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionAll 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.
Quantity in Commerce5 units
DistributionAffected devices were distributed in the US to four different medical facilities in four states
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HAW
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