FDAFebruary 23, 2016device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

x nav technologies

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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