Z-2033-2020 Class II Terminated
FDA device recall Z-2033-2020 was initiated by Advanced Bionics, LLC on February 17, 2020 and is designated Class II. Reason for recall: hearing performance degradation due to body-fluid entering the device. The recall status is terminated (terminated January 26, 2023). Affected quantity: 14068 units (CI-1600-04 = 9772 units and CI-1600-05 = 4296 units).
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- February 17, 2020
- Termination Date
- January 26, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14068 units (CI-1600-04 = 9772 units and CI-1600-05 = 4296 units)
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Canada, Brazil, Bangladesh, Switzerland, China, Australia, India, South Korea, Thailand, Ecuador, Mexico, El Salvador, Guatemala, Malaysia, Myanmar, Taiwan, Chile, Costa Rica, Colombia, Panama, Japan, Argentina, Peru, Singapore, China, New Zealand, Vietnam, Dominican Republic Refer to uploaded consignee lists in Associated Documents: Exhibit 05_ConsigneeList_Center_17FEB2020 Exhibit 06_ConsigneeList_Professionals_17FEB2020 Exhibit 07_ConsigneeList_Patients_17RFEB2020