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Advanced Bionics HiRes 90K Cochlear Implant, Model:… recallZ-2039-2009 · Advanced Bionics LLC · initiated Jun 10, 2009

Terminated All recalls posted in September 2009

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

The recall was initiated after Advanced Bionics became aware of fourteen (14) devices manufactured between May 27, 2005 and June 30, 2005 that are confirmed to have or potentially have an issue related to the internal magnet. These devices are were made with an internal magnet where the metal case surrounding the magnet was not properly welded. Patients with these devices may experience a decreas

FDA root cause category: Process control

What the company is doing

Advanced Bionics, LLC issued an "Important Notification" dated June 10, 2009 via Fed Ex to Consignees in the US and Canada. Outside of the US, the notification letters will be distributed in such a manner that delivery confirmation can be obtained. There were three type of notification letters distributed: one for Patients, one for Surgeons and one for Clinicians. Letters described the affected device prompting users on what to do next. An acknowledgement form was enclosed and should be completed and sent via fax to 1-661-362-7621. For further information, contact Advanced Bionics at 1-877-829-0026.

Recall details

Recall number
Z-2039-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 10, 2009
Posted by the FDA
Sep 11, 2009
Recalling firm
Advanced Bionics LLC
Quantity
18
Product code
MCM
FDA submissions
P960058
Distribution
Worldwide Distribution -- US, Canada, France and South Korea.

Product description

Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. Cochlear implant intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.

Code information (models, lots, serial numbers)

Serial Numbers: 225271, 301184, 225466, 225647, 225289, 225187, 300922, 225629, 225512, 301129, 300926, 225272, 225373, 300980, 225281, 225423, 225540 and 301027.

Other devices under the same FDA submission

25 devices cleared under P960058 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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