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Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New… recallZ-0003-2012 · Cochlear Americas Inc. · initiated Sep 16, 2011

Terminated All recalls posted in October 2011

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 Cochlear Americas Inc. 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

Cochlear implant may shut down and cease to function.

FDA root cause category: Component design/selection

What the company is doing

Cochlear Americas, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 16, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to examine their inventory and quarantine the affected product. A recall response form was attached to the letter for customers to complete and return. Contact Cochlear Clinic Customer Service at 877-883-3101 for questions concerning this notice.

Recall details

Recall number
Z-0003-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 16, 2011
Posted by the FDA
Oct 3, 2011
Recalling firm
Cochlear Americas Inc.
Quantity
33,645 units (global); 25,516 (implanted); 1,741 remaining in U.S. Market for implantation.
Product code
MCM
FDA submissions
P970051
Distribution
Worldwide Distribution-USA (nationwide) and countries in Europe and Australia.

Product description

Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.

Code information (models, lots, serial numbers)

Part Number Z209051 all codes.

Other devices under the same FDA submission

19 devices cleared under P970051 — 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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