Integra LifeSciences Corp.: TruDi NAV Suction Instruments Recalled for Calibration Error and Location Inaccuracy

Agency Publication Date: August 5, 2024

Summary

Integra LifeSciences Corp. is recalling approximately 265 units of TruDi NAV Suction Instruments (0 Degrees) because specific lots were incorrectly calibrated. When used with the TruDi Navigation System during ENT or skull base surgeries, this defect can cause a discrepancy between the surgical tool's actual tip location and the location shown on the navigation screen. This tool is a critical instrument used by surgeons to visualize the location of the device within a patient's body during delicate medical procedures.

Risk

The incorrect calibration can lead to a surgeon being misled about the exact position of the suction tip, potentially causing accidental damage to surrounding tissues, nerves, or blood vessels during surgery. While no specific injuries have been reported in this notice, the discrepancy between the visualized and actual location poses a risk of surgical complications.

What You Should Do

Identify your device by checking for Model/Catalog Number TDNS000Z and UDI/DI 10705031245877.
Check the packaging or hospital inventory for the following affected Lot Codes: 2310160, 2309110, 2309150, 2308140, 2308160, or 2308180.
If you possess an instrument from an affected lot, stop using it immediately and quarantine the product to ensure it is not used in future surgical procedures.
Contact Integra LifeSciences Corp. at their Princeton, NJ headquarters or through your local representative for specific instructions regarding the return or replacement of these incorrectly calibrated instruments.
Healthcare providers should consult with their surgical teams to determine if any clinical follow-up is necessary for patients where these specific lots were previously used.
For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and coordination

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: TruDi NAV Suction, 0 Degrees

Model / REF:

TDNS000Z

UPC Codes:

10705031245877

Lot Numbers:

2310160

2309110

2309150

2308140

2308160

2308180

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94955

Status: Active

Manufacturer: Integra LifeSciences Corp.

Sold By: Authorized medical distributors

Manufactured In: United States

Units Affected: 265 units

Distributed To: Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Wisconsin

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify your device by checking for Model/Catalog Number TDNS000Z and UDI/DI 10705031245877.

Check the packaging or hospital inventory for the following affected Lot Codes: 2310160, 2309110, 2309150, 2308140, 2308160, or 2308180.

If you possess an instrument from an affected lot, stop using it immediately and quarantine the product to ensure it is not used in future surgical procedures.

Contact Integra LifeSciences Corp. at their Princeton, NJ headquarters or through your local representative for specific instructions regarding the return or replacement of these incorrectly calibrated instruments.

Healthcare providers should consult with their surgical teams to determine if any clinical follow-up is necessary for patients where these specific lots were previously used.

For additional questions or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.