Alerts

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

Hazard alert - update to instructions to reduce risk of inadequate fixation

Hazard alert and recall - potential for lens to lose transparency

Hazard alert - changes to mitigate risks of multiple adverse events

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

Hazard alert and recall - potential for screws to fracture

Recall - potential for particulate contamination

Hazard alert - devices should 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 - 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Australia, in consultation with the TGA, has issued a hazard alert regarding AcrySof Cachet phakic lenses and has withdrawn the lenses from the market.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.

Zimmer, in consultation with the TGA, has issued a hazard alert regarding its NexGen Complete Knee Solution MIS total knee procedure stemmed tibial component (various sizes).

Global Orthopaedic Technology, in consultation with the TGA, is issuing a hazard alert for the MSA Hip System due to it having a higher than expected revision rate.

Consumers and health professionals are advised that Roche Diagnostic Australia, in consultation with the TGA, is undertaking a recall for product correction of its Accu-Chek Mobile blood glucose meter due to the potential for incorrect blood glucose readings as a result of users not following the device instructions.

Invacare Australia, in consultation with the TGA, is undertaking a recall for product correction of some units of its Aquatec Ocean VIP mobile shower and toilet commode