FDA recall Z-1392-2024

X-NAV Technologies, LLC · Class II · device

Product

X-Guide Handpiece Adaptor Sleeve 1, Model P010701

Reason for recall

The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.

Distribution

Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.

Key facts

Status: Ongoing
Initiation date: 2024-03-04
Report date: 2024-04-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lansdale, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1392-2024