HiResolution Bionic Ear System HiRes 90K Advantage CI recall
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Why was HiResolution Bionic Ear System HiRes 90K Advantage CI recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots, UDI (01)07630016832185 Not distributed within the US
- Product
- HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
- Recalling firm
- Advanced Bionics, LLC
- Quantity
- 4
- Distribution
- No US distribution OUS: Japan
- Recall date
- February 26, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)