FDA recall Z-0609-2019

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.

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

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

Key facts

Status

Terminated

Initiation date

2014-11-26

Report date

2018-12-26

Termination date

2019-07-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Industrial Park, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0609-2019