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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

X-NAV Technologies, LLC: X-Guide Handpiece Adaptor Sleeves Recalled for Manufacturing Defect

Agency Publication Date: March 29, 2024
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Summary

X-NAV Technologies, LLC is recalling 242 units of X-Guide Handpiece Adaptor Sleeves (Models P010701 and P010727) due to a manufacturing defect that caused incorrect geometry. This defect prevents the adaptor from fitting properly onto a doctor's dental handpiece, which could disrupt dental procedures. These devices were distributed worldwide, including throughout the United States, between March and October 2023. If you have these adaptors, you should contact the manufacturer for guidance on receiving a replacement or refund.

Risk

The incorrect geometry of the adaptor prevents it from securely attaching to the dental handpiece, which may lead to procedural delays or the inability to use the guided surgery system as intended during dental operations.

What You Should Do

  1. Check your inventory for X-Guide Handpiece Adaptor Sleeve 1 (Model P010701) with UDI-DI 00817421021480 and Lot number 2308010012.
  2. Check your inventory for X-Guide Handpiece Adaptor Sleeve 3 (Model P010727) with UDI-DI 00817421021503 and Lot numbers 2306020012 or 2310010012.
  3. Immediately stop using any affected adaptor sleeves that do not fit correctly on your dental handpiece.
  4. Contact X-NAV Technologies, LLC at their headquarters at 1555 Bustard Rd Ste 75, Lansdale, Pennsylvania, or through your authorized distributor to report the defect and arrange for a solution.
  5. Contact your healthcare provider or X-NAV Technologies, LLC directly for further instructions regarding potential replacements or refunds.
  6. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Model / REF:
P010701
UPC Codes:
00817421021480
Lot Numbers:
2308010012
Product: X-Guide Handpiece Adaptor Sleeve 3, Model P010727
Model / REF:
P010727
UPC Codes:
00817421021503
Lot Numbers:
2306020012
2310010012

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94175
Status: Active
Manufacturer: X-NAV Technologies, LLC
Sold By: X-NAV Technologies, LLC; authorized distributors
Manufactured In: United States
Units Affected: 2 products (88 units; 154 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.