X-Guide Handpiece Adaptor Sleeve 1 recall
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Why was X-Guide Handpiece Adaptor Sleeve 1 recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00817421021480; Lot: 2308010012
- Product
- X-Guide Handpiece Adaptor Sleeve 1, Model P010701
- Recalling firm
- X-NAV Technologies, LLC
- Quantity
- 88 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.
- Recall date
- April 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)