DYNASTY® A-CLASS STD Crosslinked Polyethylene Liners/ Non-constrained polyethylene acetabular liner (cancelled from Australian Register of Therapeutic Goods)
Product name
DYNASTY® A-CLASS STD Crosslinked Polyethylene Liners/ Non-constrained polyethylene acetabular liner
Sponsor
ARTG
272312
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).