X-Guide Handpiece Adaptor Sleeve 3 Manufacturing Defect Recall
X-NAV Technologies is recalling the X-Guide Handpiece Adaptor Sleeve 3 due to a manufacturing defect causing incorrect geometry that prevents proper fit. The recall affects 154 units distributed worldwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with a manufacturing defect causing improper fit. No injuries, hospitalizations, or illnesses reported. The defect would be apparent during clinical use when attempting to attach the adaptor.
Plain-English summary
The X-Guide Handpiece Adaptor Sleeve 3, Model P010727, manufactured by X-NAV Technologies, LLC, is being recalled due to a manufacturing defect. The defect causes incorrect geometry in the adaptor, preventing it from fitting properly onto dental handpieces.
The recall affects 154 units with Lot numbers 2306020012 and 2310010012 (UDI-DI: 00817421021503). These units were distributed worldwide, including the United States, China, Europe, and Japan.
Users who have received this product should stop use and contact X-NAV Technologies for instructions regarding the recalled units. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- X-Guide Handpiece Adaptor Sleeve 3, Model P010727
- Manufacturer
- X-NAV Technologies, LLC
- Hazard
- manufacturing-defect
- improper-fit
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 00817421021503
- Lot: 2306020012
- 2310010012
Distribution
Distributed nationwide across the United States.
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