Alerts

Recall for product correction due to potential for handle to break.

Recall due to replacement with newer model.

A hazard alert has been issued to cardiologists and surgeons regarding some models of Cognis Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Teligen Implantable Cardioverter Defibrillators (ICDs).

Hazard alert due to updated surgical instructions and additional quality check.

Consumers and health professionals are advised that LMT Surgical is issuing a hazard alert for all sizes and lots of its PyroTitan humeral resurfacing arthroplasty device.

It has been identified that there is a potential for some screws from the affected lot to break during insertion or removal.

Consumers and health professionals are advised that Aimedics, in consultation with the TGA, is recalling from the market all units of its HypoMon sleep-time hypoglycaemic monitor.

Zimmer is recalling from the market for the purpose of relabelling unused stock of its NexGen micro implants.

Boston Scientific has initiated a recall for product correction for multiple lots of its Promus Element Plus Monorail everolimus-eluting coronary stent system.

Novo Nordisk Pharmaceuticals has initiated a recall for product correction of certain lots of its NordiPen medical device.

Recall due to potential gas leak.

Stryker Australia has issued a hazard alert to surgeons regarding its Oasys Midline Occipital Plate.

Recall for product correction for Medtronic SynchroMed II and SynchroMed EL implantable infusion pumps.

Health professionals and consumers are advised that Medtronic Australasia is issuing a hazard alert for its Consulta Cardiac Resynchronization Therapy Pacemaker (CRT-P).

GE Healthcare has initiated a recall for product correction for a number of its nuclear medicine imaging systems.

B. Braun Australia is withdrawing the cementless version of the Columbus Knee System from the Australian Register of Therapeutic Goods (ARTG). They have also issued a related hazard alert to surgeons.

Synthes Australia, in consultation with the TGA, is recalling unused stock of its 3.7 mm and 5.0 mm Dynamic Locking Screws.

Medtronic has initiated a recall of unused stock of multiple lots of its Infuse/LT-Cage Bone Graft Kit.

Medtronic has initiated a recall for product correction for its Medtronic Paradigm insulin infusion sets.

Johnson & Johnson Medical is issuing a hazard alert to implanting surgeons regarding one lot of its Glenosphere Orientation Guide (lot number 5120443).

Johnson & Johnson Medical has initiated a recall of all unused stock and issued a hazard alert to implanting surgeons for two Codman Certas Programmable Valve products.

Health professionals and consumers are advised that Roche Diagnostics Australia, after consultation with the TGA, has initiated a recall for product correction for its CoaguChek XS, CoaguChek XS Plus and CoaguChek XS Pro INR monitors.