Class 2 Device Recall TruDi NAV Suction Instruments

• Date Initiated by Firm: March 06, 2019
• Create Date: January 19, 2020
• Recall Status: Terminated
• Recall Number: Z-0826-2020
• Recall Event ID: 84398
• 510(K)Number: K180948
• Product Classification: Ear, Nose, and Throat Stereotaxic Instrument - Product Code PGW
• Product: TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
• Code Information: Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.
• Recalling Firm/ Manufacturer: Acclarent, Inc.; 33 Technology Dr; Irvine CA 92618-2346
• For Additional Information Contact: Elsa Lbarbol; 949-450-7799
• Manufacturer Reason for Recall: The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
• FDA Determined Cause: Device Design
• Action: On 3/6/19, affected customers were contacted via Phone concerning the recall. On 3/12/19, the firm mailed a "Urgent Medical Device Recall" letter to affected customer via FedEx overnight. In addition to informing the customers about the recall, the letter asked customers to take the following actions: 1. Evaluate your current inventory of Acclarent TruDi Nav Suction Instruments with the identified lot numbers listed above. If you have inventory of the specific lots, DO NOT USE. Remove and return products immediately. 2. To return the products, complete BOTH customer acknowledgment and product return sections of the attached Business Reply Form (BRF)). A local Acclarent sales representative will contact you to retrieve the recalled products. Use the enclosed prepaid shipping label and attach a copy of the completed BRF with your product return. 3. Complete the BRF within three (3) business days of receipt even if you no longer have inventory of the identified products. Upon receipt of the completed BRF and your product return, your account will be credited. Incomplete BRFs cannot be processed. 4. Ensure that anyone in your facility who needs to be aware of this notification reads this letter carefully. 5. Maintain a copy of this communication where the inventory of the lots identified in this letter is located until all products are returned. 6. If you have product complaints or adverse events to report regarding the use of Acclarent products, please inform Acclarent by calling (650) 687-5888 7. For questions related to this issue and product recall, please contact your Acclarent sales representative or call (650) 687-5888
• Distribution: US: WI, IL, NE, CA, OH, NY OUS: None
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = PGW and Original Applicant = Acclarent, Inc.