X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. Ca
FDA device recall Z-0222-2023 · posted 2022-11-10 · Open, Classified
Recall details
- Recalling firm
- X-NAV Technologies, LLC
- 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.
- Action taken
- X-Nav issued letters dated 9/30/2022 via First Class Mail to potentially affected users on 10/3/22. Letter states reason for recall, health risk and action to take: The customers were instructed to cease use of the device until you have performed the inspection described on the second page of this letter. Review the pictures on the next page and compare them to the Probe Tool in your possession. After review, contact Customer Service at the contact options listed at the bottom of this page so that we may update our records with your findings. Report any of the below options. 1. PROBE TOOL IS GOOD. If your Probe Tool matches the good Probe Tool pictures above, it may be used as-is. 2. PROBE TOOL IS BROKEN. If your Probe Tool looks like either of the broken Probe Tool pictures above, we will send you a shipping label to return your existing Probe Tool. We will replace it with a new one free of charge. 3. YOU ARE UNSURE. If you are uncomfortable doing this inspection yourself or have doubt whether the Probe Tool is good, we will send you a shipping label to return your existing Probe Tool. We will replace it with a new one free of charge. x-navtech.com | Customer Service: 1-267-436-0420 Ext. 2 | orders@x-navtech.com
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- QRY
- Quantity affected
- 102 units
- Distribution
- US Nationwide distribution and Foreign country of: Canada
- Date initiated
- 2022-09-28
- Date posted
- 2022-11-10
- Location
- Lansdale, PA
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| Record | Firm | Date |
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| X-Guide® Surgical Navigation System (K211701) | X-Nav Technologies, LLC | 2022-02-01 |