X-NAV Technologies, LLC recalls X-Guide Handpiece Adaptor Sleeve 1, Model P010701

Recall date

March 4, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1392-2024

FDA classification

Class II

Brand / firm

X-NAV Technologies, LLC

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

X-Guide Handpiece Adaptor Sleeve 1, Model P010701