FDA Device recall Z-1391-2016
X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended t…
- FDA Device
- Class II
- terminated
- Published 2016-04-20
On 2016-04-20 the FDA classified a Class II recall of X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended t… by X Nav Technologies, citing 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 patien….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1391-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-23 |
| Published | 2016-04-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | X Nav Technologies |
| Distribution | CA, DC, FL, ID, LA, MD, NE, NM, OH, OR, PA, TN, VA, WA |
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
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
Identifiers
| code_info | Model Numbers: P007665 X-Clip; Component of System P007839. Note: P007665 X-Clip Component is distributed as X-Clip Bu…Model Numbers: P007665 X-Clip; Component of System P007839. Note: P007665 X-Clip Component is distributed as X-Clip Bulk Kit PN P008381, package of 12 pieces P007665. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1391-2016%22
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