Z-0609-2019Class II

Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used...

Name: Z-0609-2019 Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used...
Creator: Mazor Robotics Ltd
Published: 2014-11-26
License: https://open.fda.gov/license/

Mazor Robotics Ltd / initiated 2014-11-26 / Terminated / root cause: design

FDA source

Mazor Robotics Ltd began a recall of Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for... on 2014-11-26. FDA classified it as Class II and gives the reason as "In some situations the carousel position pin (locker) may cause the carousel upper plate to pop out and the carousel may then inadvertently move". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0609-2019
Classification: Class II
Status: Terminated
Initiated: 2014-11-26
Posted: 2018-12-14
Terminated: 2019-07-03
Recalling firm: Mazor Robotics Ltd
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.
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 5 units
Distribution: Affected devices were distributed in the US to four different medical facilities in four states
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0609-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0609-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-14

Product code HAW

K120812Class IIRenaissanceMazor Robotics , Ltd. / cleared 2012-07-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)