FDA Enforcement
Class II
Ongoing
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Recall: Z-1392-2024
·
Reported April 10, 2024
Enforcement
- Recall Number
- Z-1392-2024
- Event ID
- 94175
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- X-NAV Technologies, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 10, 2024
- Initiation Date
- March 4, 2024
- Classification Date
- March 29, 2024
- Address
- 1555 Bustard Rd Ste 75, Lansdale, PA, 19446-5731, United States
Description
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Reason
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.
Code Info
UDI-DI: 00817421021480; Lot: 2308010012
Distribution
Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.
Quantity
88 units