Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
X-Guide Surgical Navigation System Recalled by X-NAV Technologies, LLC Due to The X-Guide system utilizes an X-Clip (PN P007665)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact X-NAV Technologies, LLC directly.
Affected Products
X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.
Quantity: 845 units (P007665)
Why Was This Recalled?
The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. The X-Clip is a device worn intraorally by a patient during the CT scan and guided surgery procedures. The X-Clip contains three fiducial markers made from a Stainless Steel material. The X-Nav specification requires these fiducials be fabricated from Stainless Steel 3
Where Was This Sold?
This product was distributed to 14 states: CA, FL, ID, LA, MD, NE, NM, OH, OR, PA, TN, VA, WA, DC
About X-NAV Technologies, LLC
X-NAV Technologies, LLC has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report