X-NAV recalls Model P010727 Handpiece Adaptor Sleeve 3 due to incorrect geometry causing improper fit on dental handpieces. Affected units include specific lot numbers and UDI-DI codes.
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 3 (Model P010727) because a manufacturing defect causes it to not fit properly on dental handpieces. This could lead to improper use during dental procedures.
The adaptor has incorrect geometry due to a manufacturing defect, which prevents it from fitting securely onto dental handpieces. This could result in improper use during dental procedures, though the risk of serious injury is not described.
Dental professionals who own or use the X-Guide Handpiece Adaptor Sleeve 3 Model P010727 are affected. The risk is low as the defect doesn't cause immediate harm but may lead to improper function.
Check for the model number P010727 on the adaptor. Affected units include specific lot numbers: 2306020012 and 2310010012, and UDI-DI code 00817421021503.
Verify the model number on the adaptor is P010727.
The X-Guide Handpiece Adaptor Sleeve 3 (Model P010727) has a manufacturing defect causing incorrect geometry, which prevents it from fitting properly on dental handpieces.
The recall record does not specify a remedy, so no action is required beyond checking if you have the model P010727 with the listed lot numbers or UDI-DI code.
Look for the model number P010727, lot numbers 2306020012 or 2310010012, and UDI-DI code 00817421021503 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-1393-2024 — X-NAV X-NAV Hello, I own a X-NAV that is covered by recall Z-1393-2024 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.
