Recall Z-0117-2013 ยท MCM Implant, Cochlear
Advanced Bionics Corporation
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 surgica
| Date | Oct 22, 2012 (initiated Sep 14, 2007) |
| Status | Terminated |
| Reason | Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies. |
| Root 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 Acknow |
| Quantity | 17 units |
| Distribution | Worldwide distribution: USA (nationwide) including state: IL and country of: Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.