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X-NAV Technologies Recalls
4 recalls on record · April 20, 2016 to April 10, 2024 · Medical Devices
Recalls by year
16
22
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 10, 2024Medical DevicesFDA
X-NAV Technologies, LLC recalls X-Guide Handpiece Adaptor Sleeve 3, Model P010727
Hazard: 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.
April 10, 2024Medical DevicesFDA
X-NAV Technologies, LLC recalls X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Hazard: 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.
November 16, 2022Medical DevicesFDA
X-NAV Technologies, LLC recalls X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. C
Hazard: 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.
April 20, 2016Medical DevicesFDA
X-NAV Technologies, LLC recalls X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigati
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