FDA-Device2024-04-10Class II
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
X-NAV Technologies, LLC
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.
Affected count
154 units
Manufactured in
1555 Bustard Rd Ste 75, Lansdale, PA, United States
Products
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1393-2024Don't want to check this manually?
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