Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall HiResolution Bionic Ear System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall HiResolution Bionic Ear Systemsee related information
Date Initiated by FirmMarch 05, 2025
Date PostedMay 22, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1813-2025
Recall Event ID 96668
PMA NumberP960058 
Product Classification Implant, cochlear - Product Code MCM
ProductHiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Code Information M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967
Recalling Firm/
Manufacturer		 Advanced Bionics, LLC
28515 Westinghouse Pl
Valencia CA 91355-1398
For Additional Information ContactMs. Michelle Caulfield
707-481-0011
Manufacturer Reason
for Recall		Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 03/06/2025, customer service informed customers via telephone call of a distribution error. An updated "URGENT: Medical Device Recall Notification will be communicated to customers on or about 04/09/2025, via email. This updated notification will inform them that upon further review/investigation, it was identified that the individual package label was for the Marvel M Battery Charger (CI-5607), however the product within the package was a Naida CI PowerCel Charger (CI-5605). Customer are informed that: 1. The mislabeled battery charger they received was from lot either Lot Numbers: 410488967 and/or 410488966 Customers are instructed to: 2. Return the affected chargers to Advance Bionics. Advance Bionics will provide the correct charger to customer and will confirm receipt and return of the affected chargers. For questions contact customer service at 877-829-0026 or email Customerservice@advancebionics.com
Quantity in Commerce6 chargers
DistributionU.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = MCM
-
-