Z-0609-2019 Class II Terminated
FDA device recall Z-0609-2019 was initiated by Mazor Robotics Ltd on Nov 26, 2014 and is designated Class II. 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. The recall status is terminated (terminated Jul 3, 2019). Affected quantity: 5 units.
Recall details
- Product Type
- Devices
- Report Date
- Dec 26, 2018
- Initiation Date
- Nov 26, 2014
- Termination Date
- Jul 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
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.
Distribution pattern
Affected devices were distributed in the US to four different medical facilities in four states
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).
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0609-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026