Class 2 Device Recall Nada CI Q90 Sound Processor

• Date Initiated by Firm: February 06, 2019
• Create Date: April 03, 2019
• Recall Status: Terminated on February 01, 2024
• Recall Number: Z-1085-2019
• Recall Event ID: 82241
• PMA Number: P960058
• Product Classification: Implant, cochlear - Product Code MCM
• Product: Nada CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
• Code Information: Serial number 1066444, UDI (01)07630016838118(11)180725(21)1066444.
• Recalling Firm/ Manufacturer: Advanced Bionics, LLC; 28515 Westinghouse Pl; Valencia CA 91355-1398
• For Additional Information Contact: Ms. Carol Abernathy; 661-362-7580
• Manufacturer Reason for Recall: The sound processors were loaded with the incorrect firmware.
• FDA Determined Cause: Process control
• Action: On 2/6/2019, the firm began issuing letters dated February 2019 informing the recipient that corrected product was en route.
• Quantity in Commerce: 1 sound processor
• Distribution: Distribution was made to NC. Foreign distribution was made to Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran. There was no government/military distribution.
• 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.

• PMA Database: PMAs with Product Code = MCM