Recall Z-0487-2021 ยท MCM Implant, Cochlear
Advanced Bionics, LLC
AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Nada CI Q90 Sound Processor (CI-5280), Nada CI Q70 Sound Processor (CI-5245) and Nada CI Q30 Sound Processor (CI-5260). For cochlear implant.
| Date | Nov 25, 2020 (initiated Sep 26, 2020) |
| Status | Terminated |
| Reason | Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated. |
| Root cause | Under Investigation by firm |
| Action | On 9/26/2020 Advanced Bionics sent a "Field Correction Notification" to affected customers informing them about the mislabeled PowerCel Batteries. On October 5, 2020, Advanced Bionics sent a follow-up email to affected consignees. In addition, to informing consignees about the recall, the firm provided each affected consignee with the correct battery. |
| Quantity | 28 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL, SC, OH and the countries of Belgium, Germany, Italy Netherlands, Spain, Colombia, Czech Republic, Iran, Kuwait, Panama, Peru, Taiwan, Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.