Recall Z-1391-2016— X-NAV Technologies, LLC

Name: FDA recall Z-1391-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-23

Class II · Terminated

Class II FDA medical device recall by X-NAV Technologies, LLC, initiated 2016-02-23, terminated 2016-11-01. It names one FDA 510(k) clearance: K150222. 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.

Recalling firm: X-NAV Technologies, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-02-23
Terminated: 2016-11-01
Firm location: Lansdale, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K150222 — X-Guide Surgical Navigation SystemX-Nav Technologies, LLC·cleared 2015-10-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.