FDA recall Z-0397-2022

Product

VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX

Reason for recall

There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.

Distribution

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China (Mainland), China (Taiwan), Denmark, France, Germany, Italy, Japan, Netherlands, Singapore, South Korea, Spain, Thailand.

Key facts

Status

Terminated

Initiation date

2021-10-08

Report date

2021-12-29

Termination date

2024-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kalona, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0397-2022