Integra Recalls TruDi NAV Suction Instruments for Calibration Error
Integra LifeSciences has recalled 265 TruDi NAV Suction Instruments due to incorrect calibration. The miscalibrated units may display inaccurate position information during surgical navigation procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall affects a Class II medical device used in surgical procedures. No injuries or illnesses have been reported. The hazard is a potential navigation guidance error during surgery where the surgeon may rely on inaccurate position information, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corp. is recalling 265 TruDi NAV Suction Instruments (Model TDNS000Z) due to incorrect calibration. The affected units may display inaccurate suction tip position information when used with the TruDi Navigation System during ENT and skull base surgical procedures.
When incorrectly calibrated, these instruments may show a discrepancy between the actual location of the suction tip and the location displayed on the navigation system. This misalignment could affect the precision and accuracy of surgical navigation.
The recall applies only to units with specific lot codes (2310160, 2309110, 2309150, 2308140, 2308160, 2308180). The affected devices have been distributed to healthcare facilities across 33 U.S. states.
The recalled product
- Product
- TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 265
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UDI/DI: 10705031245877
- Lot Codes: 2310160
- 2309110
- 2309150
- 2308140
- 2308160
- 2308180.
Distribution
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