Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14

FDA device recall Z-0003-2012 · posted 2011-10-03 · Terminated

Recall details

Recalling firm

Cochlear Americas Inc.

Reason for recall

Cochlear implant may shut down and cease to function.

Action taken

Cochlear Americas, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 16, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their inventory and quarantine the affected product. A recall response form was attached to the letter for customers to complete and return. Contact Cochlear Clinic Customer Service at 877-883-3101 for questions concerning this notice.

Root cause

Component design/selection

Status

Terminated

Product code

MCM

Quantity affected

33,645 units (global); 25,516 (implanted); 1,741 remaining in U.S. Market for implantation.

Distribution

Worldwide Distribution-USA (nationwide) and countries in Europe and Australia.

Date initiated

2011-09-16

Date posted

2011-10-03

Date terminated

2012-07-10

Location

Englewood, CO