Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. Cochlear implant in

FDA device recall Z-2039-2009 · posted 2009-09-11 · Terminated

Recall details

Recalling firm

Advanced Bionics LLC

Reason for recall

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

Action taken

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 1-877-829-0026.

Root cause

Process control

Status

Terminated

Product code

MCM

Quantity affected

18

Distribution

Worldwide Distribution -- US, Canada, France and South Korea.

Date initiated

2009-06-10

Date posted

2009-09-11

Date terminated

2012-03-26

Location

Sylmar, CA