Device product
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
Z-1393-2024
Product summary
- Event
- Event 94175
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 154 units
- Official record key
device-enforcement:Z-1393-2024
Official wording
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 information: UDI-DI: 00817421021503; Lot: 2306020012, 2310010012
Distribution pattern: Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.
Derived failure modes
-
Manufacturing or process control
manufacturing defect