Z-0119-2010

Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited

Name: Z-0119-2010 Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited
Creator: Cochlear Americas Inc.
Published: 2009-09-30
License: https://open.fda.gov/license/

Cochlear Americas / initiated 2009-09-30 / Terminated / root cause: labeling and UDI

FDA source

Cochlear Americas Inc. began a recall of Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited on 2009-09-30. The reason FDA records is "Cochlear implant device component was mis-labeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0119-2010
Status: Terminated
Initiated: 2009-09-30
Posted: 2009-11-02
Terminated: 2009-12-22
Recalling firm: Cochlear Americas
Product: Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.
Product code: MCM Implant, Cochlear
Reason for recall: Cochlear implant device component was mis-labeled.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Part No. Z-50100.

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)