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FDASeptember 28, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

x nav technologies

UPCs

00817421020995

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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