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Cochlear nucleus CI500 implant range (recall notice)
Urgent medical device recall and hazard alert
|Date agreed:||13 September 2011|
The products being recalled under the Cochlear Nucleus CI500 Implant Range are:
|ARTG number:||see above|
|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.|
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 & II recalls are considered to be safety related recalls.