HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant syste

FDA device recall Z-0117-2013 · posted 2012-10-22 · Terminated

Recall details

Recalling firm

Advanced Bionics Corporation

Reason for recall

Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MCM

Quantity affected

17 units

Distribution

Worldwide distribution: USA (nationwide) including state: IL and country of: Europe.

Date initiated

2007-09-14

Date posted

2012-10-22

Date terminated

2012-10-22

Location

Sylmar, CA