Recall record at a glance
| Official record | Z-2033-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Advanced Bionics, LLC |
| Report date | May 27, 2020 |
| Recall initiation date | Feb 17, 2020 |
| Quantity | 14068 units (CI-1600-04 = 9772 units and CI-1600-05 = 4296 units) |
| Location | Valencia, CA, United States |
Official product description
AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
Why the product was recalled
hearing performance degradation due to body-fluid entering the device.
Distribution information
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
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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