Advanced Bionics Cochlear Implant Electrode Recalled for Documentation Error
Advanced Bionics is recalling four HiResolution Bionic Ear System electrodes in Japan because three materials were omitted from the approved bio-compatibility list.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a documentation error regarding the list of bio-compatible materials, with no reported injuries or illnesses.
Plain-English summary
Advanced Bionics, LLC is recalling four units of the HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode (REF CI-1500-04). The recall affects all lots of this specific product, identified by UDI (01)07630016832185.
The recall was initiated because three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. This is a documentation and regulatory compliance issue regarding the materials listed in the approval process.
The product was not distributed within the United States. The distribution was limited to Japan. Consumers in the United States are not affected by this recall.
The recalled product
- Product
- HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
- Manufacturer
- Advanced Bionics, LLC
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All Lots
- UDI (01)07630016832185 Not distributed within the US
Distribution
Distribution scope not specified by the agency.
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