Z-0003-2012

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

Name: Z-0003-2012 Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia...
Creator: Cochlear Americas Inc.
Published: 2011-09-16
License: https://open.fda.gov/license/

Cochlear Americas / initiated 2011-09-16 / Terminated / root cause: design

FDA source

Cochlear Americas Inc. began a recall of Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia... on 2011-09-16. The reason FDA records is "Cochlear implant may shut down and cease to function". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0003-2012
Status: Terminated
Initiated: 2011-09-16
Posted: 2011-10-03
Terminated: 2012-07-10
Recalling firm: Cochlear Americas
Product: Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.
Product code: MCM Implant, Cochlear
Reason for recall: Cochlear implant may shut down and cease to function.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Part Number Z209051 all codes.

Product code MCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)