Recall Z-1392-2024— X-NAV Technologies, LLC

Name: FDA recall Z-1392-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-04

Class II · Ongoing

Class II FDA medical device recall by X-NAV Technologies, LLC, initiated 2024-03-04. It names one FDA 510(k) clearance: K232148. Product: X-Guide Handpiece Adaptor Sleeve 1, Model P010701. Reason: 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..

Recalling firm: X-NAV Technologies, LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-03-04
Firm location: Lansdale, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K232148 — X-Guide Surgical Navigation SystemX-Nav Technologies, LLC·cleared 2024-02-21

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 Handpiece Adaptor Sleeve 1, Model P010701

Reason for recall

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.

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