TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005

When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.

On 9/21/23, correction notices were mailed to customers who were asked to do the following: Please cease using the affected curette device with the affected navigation system until the new version of navigation system software version 2.3.2 is installed. 2. Please do not return any of the curettes within your inventory. 3. Complete and return the business response form via email to [email protected] 4. Forward this notice to any personnel in your facility that needs to be informed. 5. If any of the affected products have been forwarded to another facility, contact that facility and provide a copy of this to the relevant personnel. 6. Post a copy of this notice in a visible area for awareness If any adverse reactions or quality problems are experienced during the use of the affected navigation system with the curette, please report any issues to the firm via the product complaint phone number:1-877-775-2789, Option # 5.