Class II

Medical Device Recall: X-Guide Handpiece Adaptor Sleeve 3, Model P010727

X-NAV Technologies, LLC · March 4, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

154 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1393-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

X-NAV Technologies, LLC Medical Device Recall: X-Guide Handpiece Adaptor Sleeve 3, Model P010727 | SafeCheck