Summary
The FDA issued a Class II for X-Guide Handpiece Adaptor Sleeve 1, Model P010701 by X-NAV Technologies, LLC. Reason: The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not f.
Details
Source
Device Recall
External ID
Z-1392-2024
Action Date
2024-04-10
Status
Ongoing
Category
device
Product Description
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Lot/Code Info: UDI-DI: 00817421021480; Lot: 2308010012
Quantity Affected: 88 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-04
Company
Lansdale, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
X-NAV Technologies, LLC has 5 FDA actions in our database, including 3 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (X-NAV Technologies, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does X-NAV Technologies, LLC have FDA actions?
X-NAV Technologies, LLC has 5 FDA actions in our database, including 3 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1392-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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