X-Guide Handpiece Adaptor Sleeve defect affects fit on dental handpiece
The X-Guide Handpiece Adaptor Sleeve 1 may have a manufacturing defect causing incorrect geometry that prevents proper fit on dental handpieces. Approximately 88 units are affected.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device with a manufacturing defect affecting functionality and preventing proper use. While no illnesses or injuries have been reported, a dental instrument that does not fit properly presents a potential risk of harm during clinical use.
Plain-English summary
The X-Guide Handpiece Adaptor Sleeve 1, Model P010701, manufactured by X-NAV Technologies, LLC, is being recalled due to a manufacturing defect causing incorrect geometry. This defect prevents the adaptor from fitting properly onto dental handpieces.
Approximately 88 units of this product are affected by this recall. The affected units were distributed worldwide, including across the United States, China, Europe, and Japan. The affected lot is 2308010012 (UDI-DI: 00817421021480).
The FDA has classified this as a Class II recall.
The recalled product
- Product
- X-Guide Handpiece Adaptor Sleeve 1, Model P010701
- Manufacturer
- X-NAV Technologies, LLC
- Affected units
- 88
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 (2)
- UDI-DI: 00817421021480
- Lot: 2308010012
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.
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