Prosthesis, internal, joint, hip, acetabular component (Cancelled from the ARTG under s.41GN(1)(e) and the ARTG entry varied under s.41GO)
Product name
Prosthesis, internal, joint, hip, acetabular component
Sponsor
ARTG
122258
Date action takes effect
Compliance action
Medical device cancellation - certain devices within an entry
Type of action
Cancelled from the ARTG under s.41GN(1)(e) and the ARTG entry varied under s.41GO
Grounds for regulatory action
The Secretary is satisfied that the safety and performance of some devices included in the entry are unacceptable. However, as other devices of the same kind are included under the ARTG entry, the entry has been varied to exclude this device: Selexys Acetabular Component TPS and TH+.
Device names
Selexys Acetabular Component TPS and TH+