Recall Z-0119-2010 ยท MCM Implant, Cochlear
Cochlear Americas Inc.
Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.
| Date | Nov 2, 2009 (initiated Sep 30, 2009) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.