Recall Z-0222-2023— X-NAV Technologies, LLC

Name: FDA recall Z-0222-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-28

Class II · Ongoing

Class II FDA medical device recall by X-NAV Technologies, LLC, initiated 2022-09-28. It names one FDA 510(k) clearance: K211701. Product: X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Catalog Number:P010673. Reason: 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..

Recalling firm: X-NAV Technologies, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-09-28
Firm location: Lansdale, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K211701 — X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC·cleared 2022-02-01

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

Reason for recall

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.

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