Class II — X-NAV Technologies, LLC
| Recalling firm | X-NAV Technologies, LLC. |
|---|---|
| Registered facility | X-NAV TECHNOLOGIES, LLC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Product | 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) |
| Distribution | US Distribution to: FL, OR, NE, PA, NM, FL, VA, OH, WA, CA, MD, LA, ID, CN, TN, and DC. |
| Initiated | 2016-02-23 |
| Classified | 2016-04-14 |
| Terminated | 2016-11-01 |
| Recall number | Z-1391-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — X-NAV Technologies, LLC (Z-1391-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73544/
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