X-Guide Surgical Navigation System — Class II medical device recall Z-1391-2016
Terminated recall by X-NAV Technologies, LLC, reported 2016-04-20, distributed in CA, DC, FL, ID, LA, MD, NE, NM…. The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the
| Recall number | Z-1391-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | X-NAV Technologies, LLC, Lansdale, PA, United States |
| Recall initiated | 2016-02-23 |
| Classified | 2016-04-14 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2016-11-01 |
| Distributed | CA, DC, FL, ID, LA, MD, NE, NM, OH, OR, PA, TN, VA, WA |
| Quantity | 845 units |
| Model numbers | P007665 |
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.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1391-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.