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Cochlear nucleus CI500 implant range (recall notice)

Urgent medical device recall and hazard alert

This recall follows a recent increase in the number of failures of CI512 implant in the Cochlear Nucleus CI500 Implant range. 

Published
Level:Hospital
Class:II
Reference:RC-2011-RN-00920-3
Date agreed:13 September 2011
Product:

The products being recalled under the Cochlear Nucleus CI500 Implant Range are:

ARTG number:see above
Sponsor:Cochlear Ltd
Contact:If patients notice that their implant has ceased to function, they should contact their medical practitioner, audiologist or hearing clinic.
Reason:

This recall follows a recent increase in the number of failures of CI512 implant in the Cochlear Nucleus CI500 Implant range. 

The information currently available to the TGA is that less than 1% of these implants have failed. 

The root cause of the problem is under investigation.

Classification system:

Class I defects are potentially life-threatening or could cause a serious risk to health.

Class II defects could cause illness or mistreatment, but are not Class I.

Class III defects may not pose a significant hazard to health, but withdrawal may be initiated for other reasons.

Class I and II recalls are considered to be safety related recalls.

Product types