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 procedures in ENT medicine and skull base surgery

Recall number

Z-2507-2024

Recalling firm

Integra LifeSciences Corp.

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

Status

Open, Classified

Initiated

2024-07-09

Posted

2024-08-05

Terminated

not on file

Reason

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

Process control

Action

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

Quantity

265 units

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.

Lot, serial or model codes

UDI/DI: 10705031245877; Lot Codes: 2310160, 2309110, 2309150, 2308140, 2308160, 2308180.

510(k) numbers

["K180948"]

PMA numbers

not on file

Product code

PGW

Firm FEI

3003418325

Firm city

Princeton

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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