FDAFDA · Food and drugs·Recall number Z-1393-2024
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
Published April 10, 2024 · Recall initiated: March 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- X-NAV Technologies, LLC
- Distributor
- Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.
- Lot
- UDI-DI: 00817421021503; Lot: 2306020012, 2310010012
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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