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Terminated

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

FDA Recall Z-0119-2010 · Posted 2009-11-02

Recalling FirmCochlear Americas Inc.
Recall StatusTerminated
Product CodeMCM
Date Initiated2009-09-30
Date Terminated2009-12-22
Product Quantity10 units

Reason for Recall

Cochlear implant device component was mis-labeled.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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