| 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 & II recalls are considered to be safety related recalls.