Cochlear Americas Inc. Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.
Brand
Cochlear Americas Inc.
Lot Codes / Batch Numbers
Part No. Z-50100.
Products Sold
Part No. Z-50100.
Cochlear Americas Inc. is recalling Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited. due to Cochlear implant device component was mis-labeled.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Cochlear implant device component was mis-labeled.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026