X-NAV Technologies, LLC: Medical Device Recall in 2016 - (Recall #: Z-1391-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 23, 2016

Date Posted: April 20, 2016

Recall Number: Z-1391-2016

Event ID: 73544

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

Status: Terminated

Product Quantity: 845 units (P007665)

Code Information:

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.

Distribution Pattern:

US Distribution to: FL, OR, NE, PA, NM, FL, VA, OH, WA, CA, MD, LA, ID, CN, TN, and DC.

Voluntary or Mandated:

Voluntary: Firm initiated