FDA Medical Device Recalls (openFDA)
Cochlear Americas Inc.: 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.
- Recall number
- Z-0003-2012
- Recalling firm
- Cochlear Americas Inc.
- 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.
- Status
- Terminated
- Initiated
- 2011-09-16
- Posted
- 2011-10-03
- Terminated
- 2012-07-10
- Reason
- Cochlear implant may shut down and cease to function.
- 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
- 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.
- Lot, serial or model codes
- Part Number Z209051 all codes.
- 510(k) numbers
- not on file
- PMA numbers
- ["P970051"]
- Product code
- MCM
- Firm FEI
- 3005900820
- Firm city
- Englewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28