We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
DYNASTY® PC Porous Beaded Shell/Metallic acetabulum prosthesis (cancelled from Australian Register of Therapeutic Goods)
Product name
DYNASTY® PC Porous Beaded Shell - Metallic acetabulum prosthesis
Sponsor
ARTG
272232
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under subsection 41GN(1)(b) of the Act
Grounds for regulatory action
As the sponsor did not provide information to substantiate compliance with the Essential Principles, the sponsor failed to comply with a condition to which inclusion of the kind of device in the ARTG was subject under s.41FN(3)(a).
Secondly, the Sponsor has failed to comply with conditions imposed after kinds of medical devices are included in the Register (see subsection 41FP(1)(a) of the Act).