X-NAV recalls Model P01070: Handpiece Adaptor Sleeve 1 with incorrect geometry that prevents proper fitting onto dental handpieces. Affected units sold from 2023.
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.
X-NAV is recalling its X-Guide Handpiece Adaptor Sleeve 1 (Model P010701) because it may have incorrect geometry that prevents it from fitting properly onto dental handpieces. This could lead to improper use during dental procedures.
The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. This means it might not fit onto the doctor's dental handpiece, potentially leading to improper use during dental procedures.
Dental professionals who own or use the X-Guide Handpiece Adaptor Sleeve 1 (Model P010701) are likely affected. The risk is low as the issue only affects proper fitting, not safety.
Check for the model number P010701 on the product. Units sold from 2023 with UDI-DI: 00817421021480 and Lot: 2308010012 are affected.
Ensure the adaptor fits securely onto the dental handpiece. If it does not fit, stop using it.
No, the hazard is only that the adaptor may not fit properly, which could lead to improper use during dental procedures. It does not pose a risk of injury.
If the adaptor does not fit securely onto the dental handpiece, stop using it and contact X-NAV for guidance.
Check for the model number P010701, UDI-DI: 00817421021480, and Lot: 2308010012 on the product.
We’ve drafted a message you can send X-NAV to request your refund or repair — edit it as you like.
Subject: Recall Z-1392-2024 — X-NAV X-NAV Hello, I own a X-NAV that is covered by recall Z-1392-2024 from X-NAV. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
