Class 2 Device Recall HiRes 90K

• Date Initiated by Firm: September 14, 2007
• Date Posted: October 22, 2012
• Recall Status: Terminated on October 22, 2012
• Recall Number: Z-0117-2013
• Recall Event ID: 63353
• Product Classification: Implant, cochlear - Product Code MCM
• Product: HiRes 90K devices with Helix Electrodes Model CI 1400-02H; ; The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal components include a stimulator (HiRes90K ICS) and electrode array (HiFocus 1j or Helix). The HiRes90K ICS is implanted surgically under the skin behind the ear. The electrode array is inserted into the cochlea. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. The Helix consists of a fantail, electrode lead, and Helix electrode array. The electrode, comprised of platinum-iridium wires, is housed in a silicone carrier and extends from the titanium case. The Helix electrode array is 24.5 mm in length and is designed to be inserted approximately 18-21 mm into a normal patent cochlea. It consists of 16 planar contacts arranged along the medial surface of the electrode array for stimulation of discrete segments of the cochlea. The Helix electrode insertion tool is designed to assist the surgeon with the insertion of the Helix electrode. Only the Helix insertion should be used for insertion of the Helix electrode; the use of other instruments may result in damage to the electrode. The insertion tool is a single-use instrument.
• Code Information: Serial Numbers: 351323, 251153, 350989, 351226, 350196, 351136, 350140, 350201, 351261, 351264, 351266, 351269, 351412, 351415, 351429, 350157, 351303.
• Recalling Firm/ Manufacturer: Advanced Bionics Corporation; 12740 San Fernando Rd; Bldgs. 1 & 3; Sylmar CA 91342
• Manufacturer Reason for Recall: Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm, Advanced Bionics, sent a " RECALL NOTIFICATION" letter dated September 14, 2007 to all their customers who purchased the HiRes 90K devices with Helix Electrodes Model CI 1400-02H. The letter identified the product, problem, and actions to be taken. The customers were instructed to immediately locate and return the affected product to Advanced Bionics. The firm's Service representative will contact the customers within 48 hours to retrieve the affected product and send a replacement as needed. The customers were also instructed to complete and return the enclosed Notification Acknowledgement form via fax to: (661) 362-1511. If you have any questions regarding this letter, call Advanced Bionics at (877) 829-0026 between the hours of 5 AM and 5 PM Pacific Time, Monday through Friday.
• Quantity in Commerce: 17 units
• Distribution: Worldwide distribution: USA (nationwide) including state: IL and country of: Europe.
• 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.