X-NAV Technologies

4 recalls •

• Categories: Other Medical Devices, Implants & Prosthetics

X-Guide Handpiece Adaptor Sleeve 3, Model P010727

Class I - Dangerous

The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.

Mar 4, 2024 Other Medical Devices Nationwide View Details →

X-Guide Handpiece Adaptor Sleeve 1, Model P010701

Class I - Dangerous

The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.

Mar 4, 2024 Other Medical Devices Nationwide View Details →

X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673

Class I - Dangerous

Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registration and fall into the patient s mouth. In this case, the patient may aspirate or swallow the probe tip.

Sep 28, 2022 Other Medical Devices Nationwide View Details →

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.

Class I - Dangerous

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

Feb 23, 2016 Implants & Prosthetics View Details →