—#208933

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

FDA product code: PGW — Ear, Nose, And Throat Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K180948
Affected lot / code info: UDI/DI: 10705031245877; Lot Codes: 2310160, 2309110, 2309150, 2308140, 2308160, 2308180.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

On July 9, 2024 URGENT VOLUNTARY MEDICAL DEVICE RECALL (REMOVAL) letters were sent to consignees. What Actions Are Required: 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). 2. Remove the product subject to this recall and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 4. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and email it to Sedgwick at Acclarent8029@sedgwick.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 5. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to Sedgwick. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records. 6. To return product subject to this recall, photocopy the completed Business Reply Form (BRF), place it in the return kit box received with the product, and affix the pre-paid authorized shipping label included with the return kit. Acclarent will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be obtained by calling 855-215-5039. Keep the original Business Reply Form (BRF) for your records. 7. To receive replacement, customers must return product subject to this recall by August 31, 2024. Any non-affected product that is sent to Sedgwick will not receive replacement nor will the product be returned. DO NOT return impacted product to Acclarent, replacement will not be given, nor will the product be returned. If you have product complaints or adverse events to report regarding t

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

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.

Timeline

Recall initiated: 2024-07-09
Posted by FDA: 2024-08-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208933. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.