Alerts

Hazard alert - potential for implant failure due to poor fixation

Hazard alert - updated instructions to reduce risk of complications.

Recall for product correction - Update to instructions to prevent blood loss if unit malfunctions.

Hazard alert due to higher-than-expected revision rate.

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

Hazard alert due to risk of premature battery depletion that may lead to early device replacement.

Hazard alert due to update to instructions to reduce risk of inadequate fixation.

Hazard alert due to changes to mitigate risks of multiple adverse events.

Hazard alert and recall due to potential for lens to lose transparency.

Hazard alert due to components mixed during manufacturing leading to increased risk of need for revision.

Hazard alert and recall due to potential for screws to fracture.

Recall - potential for particulate contamination

Hazard alert due to devices no longer be used to treat migraine.

Hazard alert - potential for temporary malfunction during automated testing

Hazard alert - potential for valve to move after implantation.

Recall - may contain incorrect gel

Hazard alert due to potential for component fracture.

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.

Recall - potential for particulate contamination

Alcon Laboratories Australia, in consultation with the TGA, has issued a hazard alert regarding AcrySof Cachet phakic lenses and has withdrawn the lenses from the market.

Boston Scientific, in consultation with the TGA, has issued a hazard alert to cardiologists and surgeons regarding some models of Cognis Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Teligen Implantable Cardioverter Defibrillators (ICDs).

Wright Medical Australia has issued a hazard alert regarding specific lots of its Claw and Claw II plates. Wright Medical Australia is also recalling unused stocks of the affected lots.

St Jude Medical, in consultation with the TGA, has issued a hazard alert regarding a potential issue with its Ellipse family of implantable cardioverter defibrillators (ICDs).

Johnson & Johnson Medical, in consultation with the TGA, has issued a hazard alert for two Codman Certas Programmable Valve products.

Hazard alert due to faulty threads potentially preventing installation of drop-down stem extension or stem plug.