Mazor Robotics Ltd: Medical Device Recall in 2018 - (Recall #: Z-0609-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 26, 2014

Date Posted: December 26, 2018

Recall Number: Z-0609-2019

Event ID: 81521

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.

Status: Terminated

Product Quantity: 5 units

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).

Distribution Pattern:

Affected devices were distributed in the US to four different medical facilities in four states

Voluntary or Mandated:

Voluntary: Firm initiated