Integra LifeSciences Corp.: Device Recall

Recall Details

Recall Number

Z-2507-2024

Classification

Class II

Product Type

Device

Recalling Firm

Integra LifeSciences Corp.

Status

Ongoing

Date Initiated

07/09/2024

Location

Princeton, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

265 units

Reason for Recall

Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.

Product Description

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

Distribution Pattern

The devices are only sold in the US. The following states have received the product: AL, AZ CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, PA, SC, SD, TN, TX, VA, VT, WI.

Other Recalls by Integra LifeSciences Corp.

• Class II: Risk 02/06/2025
  Possibility for the obturator to break (separate).
• Class II: Risk 01/10/2025
  Potential that the induction seal is not completely sealed to the device tube packaging.
• Class II: Risk 12/16/2024
  Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
• Class II: Risk 12/16/2024
  Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
• Class II: Risk 12/16/2024
  Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

View all recalls by Integra LifeSciences Corp. →