Integra LifeSciences Corp.: TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedur

Hazard

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.

Details from the source

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. Distribution: 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. Quantity: 265 units Lot/code info: UDI/DI: 10705031245877; Lot Codes: 2310160, 2309110, 2309150, 2308140, 2308160, 2308180.

UPC codes

10705031245877

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.