Recall Z-0957-2009 ยท MCM Implant, Cochlear
Advanced Bionics LLC
Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss
| Date | Feb 3, 2009 (initiated Jul 24, 2008) |
| Status | Terminated |
| Reason | Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but can |
| Root cause | Employee error |
| Action | Advanced Bionics is notifying clinicians of this situation so that they can provide appropriate clinical management. The notification letter sent to clinicians in the United States was sent via FedEx so that delivery information could be confirmed. The letter advises that Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Auria and Harmony headpieces are not affected by this issue. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the |
| Quantity | 2,123 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.