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HiRes 90K Advantage CI HiFocus MS Electrode recallZ-1259-2020 · Advanced Bionics, LLC · initiated Mar 18, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Advanced Bionics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Other

What the company is doing

On March 18, 2019, the firm sent a "Voluntary Field Action" letter was sent to Japanese surgeons who implanted the device. The firm has stopped sales until the documentation is finalized. The field action letter informed customers that the action was due to an error in documentation and poses no risk to patient safety. The serial numbers of implanted HiRes90K Advantage cochlear implants with 1J and MS electrodes will be made available on the PMDA website.

Recall details

Recall number
Z-1259-2020
Status
Terminated
Initiated by the company
Mar 18, 2019
Posted by the FDA
Feb 18, 2020
Recalling firm
Advanced Bionics, LLC
Quantity
4
Product code
MCM
FDA submissions
P960058
Distribution
No US distribution OUS: Japan

Product description

HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.

Code information (models, lots, serial numbers)

All Lots, UDI (01)07630016832185  Not distributed within the US

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

24 devices cleared under P960058 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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