HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Reported: February 26, 2020 Initiated: March 18, 2019 #Z-1259-2020
Product Description
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Reason for Recall
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.
Details
- Recalling Firm
- Advanced Bionics, LLC
- Units Affected
- 4
- Distribution
- No US distribution OUS: Japan
- Location
- Valencia, CA
Frequently Asked Questions
What product was recalled? ▼
HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.. Recalled by Advanced Bionics, LLC. Units affected: 4.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2020. Severity: Low. Recall number: Z-1259-2020.
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