Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.
FDA device recall Z-0119-2010 · posted 2009-11-02 · Terminated
Recall details
- Recalling firm
- Cochlear Americas Inc.
- Reason for recall
- Cochlear implant device component was mis-labeled.
- Action taken
- 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
- Status
- Terminated
- Product code
- MCM
- Quantity affected
- 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.
- Date initiated
- 2009-09-30
- Date posted
- 2009-11-02
- Date terminated
- 2009-12-22
- Location
- Englewood, CO
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