Recall Z-2039-2009 ยท MCM Implant, Cochlear
Advanced Bionics LLC
Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. Cochlear implant intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
| Date | Sep 11, 2009 (initiated Jun 10, 2009) |
| Status | Terminated |
| Reason | The recall was initiated after Advanced Bionics became aware of fourteen (14) devices manufactured between May 27, 2005 and June 30, 2005 that are confirmed to have or potentially have an issue related to the internal magnet. These devices are were made with an internal magnet where the metal case surrounding the magnet was not properly welded. Patients with these devices may experience a decreas |
| Root cause | Process control |
| Action | Advanced Bionics, LLC issued an "Important Notification" dated June 10, 2009 via Fed Ex to Consignees in the US and Canada. Outside of the US, the notification letters will be distributed in such a manner that delivery confirmation can be obtained. There were three type of notification letters distributed: one for Patients, one for Surgeons and one for Clinicians. Letters described the affected device prompting users on what to do next. An acknowledgement form was enclosed and should be completed and sent via fax to 1-661-362-7621. For further information, contact Advanced Bionics at 1-877 |
| Quantity | 18 |
| Distribution | Worldwide Distribution -- US, Canada, France and South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.