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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 154
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.
Part of a larger recall action
This product is one of 2 recalled by X-NAV Technologies, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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