Z-1392-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2024
- Initiation Date
- March 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88 units
Product Description
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
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 Pattern
Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.
Code Information
UDI-DI: 00817421021480; Lot: 2308010012