FDA Medical Device Recalls (openFDA)
Cochlear Americas Inc.: Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.
- Recall number
- Z-0119-2010
- Recalling firm
- Cochlear Americas Inc.
- Product
- Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.
- Status
- Terminated
- Initiated
- 2009-09-30
- Posted
- 2009-11-02
- Terminated
- 2009-12-22
- Reason
- Cochlear implant device component was mis-labeled.
- Root cause
- Labeling mix-ups
- Action
- On September 28, 2009, each surgeon who received a non-magnetic plug after December 5, 2008 was sent a notification letter via courier. The letter described the mislabeling issue and actions for consignees. Customers were requested to return affected product (and the quantity discarded) to the firm and review patient records to verify the implantation of the non-magnetic plug and not the mislabled product (sterile magnetic). Direct questions about the recall by calling at 1-800-523-5798.
- Quantity
- 10 units
- Distribution
- Worldwide Distribution -- United States (AL, AZ, CA, GA, IA, NC, MA, MI, MN, MO, NY, OH, OR, PA, TN, TX and WA), Brazil, and Argentina.
- Lot, serial or model codes
- Part No. Z-50100.
- 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