Type of Product |
Medical Device |
TGA Recall Reference |
RC-2016-RN-01457-1 |
Product Name/Description |
ROTAIO Cervical Disc Prosthesis
ARTG Number: 216748 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
23/11/2016 |
Responsible Entity |
|
Reason/Issue |
In the postoperative course patients reported a temporary or permanent development of noise. Concerned were approx. 0.12 % of the disc prostheses. In some individual cases the doctors in charge decided to remove the implant. Extensive analyses by the manufacturer, Signus Medizintechnik has not identified any indications as to the causes of the noise development as yet. Examinations of implants removed and reference implants performed in that context showed that the prostheses were properly manufactured and fully functional with no structural defects or abnormal signs of wear and tear. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
The manufacturer is adding the possible side effect “temporary or permanent noise development” in the Instructions For Use (IFU).
This action has been closed out on the 12/11/2018. |
Contact Information |
02 9006 1662 - Emergo Australia |