Alerts

Product defect correction - lid magnet may dislodge and cause early battery depletion

Hazard alert - titanium modular necks pose small risk of fracture

Product defect correction – risk of delayed therapy due to potential battery issues

Recall of multiple products - potential for breaches of sterile packaging

Recall for product correction - potential for injury due to breakage of the seating system

Hazard alert – risk of sudden loss of therapy due to reduced battery performance

Recall – potential failure to activate or need to apply increased force to activate

Hazard alert - higher than expected rate of PE inlay breakage

Hazard alert - higher than expected revision rate when used without patella resurfacing

Hazard alert - potential for implant failure due to poor fixation

Recall for product correction - risk of peritonitis due to separated, partially protruding or missing sponge

Hazard alert - potential for temporary malfunction during automated testing

Hazard alert - potential for valve to move after implantation.

Consumers and health professionals are advised that Roche Diagnostic Australia, in consultation with the TGA, has initiated a recall for product correction for its Accu-Chek Spirit Combo insulin pumps.

Medtronic Australasia has issued a hazard alert regarding two potential issues involving multiple models of its deep brain stimulation and spinal cord stimulation devices.

PIP breast implants: Consumer questions & answers

GlaxoSmithKline (GSK) and Alphapharm, in consultation with the TGA, are undertaking a voluntary recall of several batches of Ventolin and Asmol inhalers due to a fault in the delivery mechanism of a small number of inhalers within each batch. This can lead to less than the full dose being delivered for each puff.

The Therapeutic Goods Administration (TGA) advises that the R3 metal liner component of the R3 acetabular system (used in hip replacements) is being recalled by the Australian sponsor, Smith & Nephew Surgical Pty Ltd.

Information on the management of issues related to the recall of PIP silicone gel breast implants

Information on the management of issues related to the recall of PIP silicone gel breast implants

The TGA advises that while PIP breast implants were recalled due to the use of unauthorised silicone, current evidence does not support routine removal in patients without symptoms, and individuals are encouraged to seek medical advice if concerned.

At the time of writing, the TGA has been advised that approximately 9,054 PIP breast implants have been implanted by surgeons between 2002 and 2010. In April 2010 non-implanted PIP breast implants were recalled from the Australian marketplace.