Australian healthcare regulators this month issued a hazard alert on a single lot of Johnson & Johnson’s (NYSE:JNJ) surgical assist devices after it was discovered that the orientation guides had arrows on the wrong side, possibly leading to incorrect placement.
The affected lot of devices – a guiding instrument called the Glenosphere Orientation Guide used for the company’s Delta XTEND Reverse Shoulder System – was removed from Australian circulation in March. However, because the guide is reusable, it’s possible that some faulty devices are still in clinics.
The Australian Department of Health instructed patients who have recently had shoulder surgery to visit their doctor, especially if they experience pain or reduced range of motion. The health regulators stopped short of recommending preventative removal of the devices, but advised physicians to consider revision surgery "if symptoms are evident and incorrect placement is suspected."
J&J is in hot water Down Under for another of its devices. The company’s subsidiary Ethicon Endo-Surgery pulled certain Ligaclip devices from hospital shelves on the risk of malformed clips failing to occlude the target vessel or structure.