HiRes 90K devices with Helix Electrodes recall
HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful…
Why was HiRes 90K devices with Helix Electrodes recalled?
Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.
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?
Serial Numbers: 351323, 251153, 350989, 351226, 350196, 351136, 350140, 350201, 351261, 351264, 351266, 351269, 351412, 351415, 351429, 350157, 351303.
- Product
- HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful…
- Recalling firm
- Advanced Bionics Corporation
- Quantity
- 17 units
- Distribution
- Worldwide distribution: USA (nationwide) including state: IL and country of: Europe.
- Recall date
- October 31, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)