Orthopaedic external fixation system, single-use, sterile (Cancellation from the ARTG under subsection 41GN(1) of the Act.)
Product name
Orthopaedic external fixation system, single-use, sterile
ARTG
317164
Date action takes effect
Compliance action
Medical device cancellation
Type of action
Cancellation from the ARTG under subsection 41GN(1) of the Act.
Grounds for regulatory action
The sponsor failed to comply with an automatic condition of inclusion under subsection 41FN(5A) of the Act. The sponsor did not provide information to the TGA about that kind of medical device on an annual basis for the first three years of the kind of device's inclusion. The TGA notified the sponsor of the cancellation on 13 May 2021. On 21 May 2021, the sponsor voluntarily cancelled the ARTG inclusion.