Stryker’s spinal stabilization plate is part of the Oasys spinal surgery system. Regulators learned that after surgery the pin connecting to the plate body can break, possibly causing patient harm and requiring revision surgery.
Australia’s Department of Health & Ageing issued a hazard alert based on reported cases of device malfunction in the U.S. and Belgium. Stryker’s Australian subsidiary jointly issued the alert, which is not as extreme as a device recall.
"The root cause of the problem is not yet known and the manufacturer is continuing to investigate reported cases from the USA and Belgium," according to the Aussie report. "To minimize risk to patients, Stryker Australia has removed this device from the market until the definitive root cause is identified."
Recall issues have plagued Michigan-based orthopedics giant Stryker this year. During the past 2 quarters the company has cited recall-associated costs among drivers of lower profits. Last week, Stryker saw 2nd-quarter profits plunge nearly 35% on costs related to the recall of its Rejuvenate hip implant, forcing the device giant to lower its 2013 outlook. The same recall dragged down Q1 profits by about 13%.