Recall Z-0796-2011 ยท MCM Implant, Cochlear
Advanced Bionics Corporation
Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-02H The Harmony HiResolution Bionic Ear system is a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss.
| Date | Dec 21, 2010 (initiated Nov 23, 2010) |
| Status | Terminated |
| Reason | The recall action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device. |
| Root cause | Pending |
| Action | Advanced Bionics (AB) Personal contacted all centers with known surgeries about the recall by telephone on November 22, 2010, and sent Blastfax to affected surgeons and clinicians. AB forwarding a Press Release on November 23, 2010 to the Business Wire News Trak. The firm also faxed Health Care Provider letters to the affected Health Care Providers and placed a Patient notification letter on the AB website on November 23, 2010. Health Care Provider letters were FedEx'ed November 24, 2010 to the affected Health Care Providers. Patient Letters were sent via FedEx'ed beginning Monday November |
| Quantity | 82 units |
| Distribution | Nationwide distribution: AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.