Z-2507-2024Class II

TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for...

Name: Z-2507-2024 TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for...
Creator: Integra LifeSciences Corp.
Published: 2024-07-09
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2024-07-09 / Open, Classified / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during... on 2024-07-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2507-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-09
Posted: 2024-08-05
Recalling firm: Integra LifeSciences Corporation
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
Product code: PGW Ear, Nose, And Throat Stereotaxic Instrument
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.
Root cause tag: manufacturing process
FDA 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 [email protected] 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 in commerce: 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.
Product codes and lots: UDI/DI: 10705031245877; Lot Codes: 2310160, 2309110, 2309150, 2308140, 2308160, 2308180.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2507-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2507-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-05

Product code PGW

K180948Class IITruDi NAV Suction InstrumentsAcclarent, Inc. / cleared 2018-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)