Reported Apr 10, 2024 · Ongoing
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
X-NAV Technologies, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: X-NAV Technologies, LLC · 1555 Bustard Rd Ste 75 · Lansdale, PA · 19446-5731
Is this the product you have?
X-Guide Handpiece Adaptor Sleeve 1Model P010701
- Lot codes and dates
- UDI-DI00817421021480
- Lot2308010012
- Amount recalled
- 88 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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