Stryker pulls spinal devices off the shelves following failure reports

July 23, 2013 by Sony Salzman

The Australian health department sounds the alarm on Stryker's Oasys Midline Occipital Plate after problems are reported in the U.S. and Belgium.

Hazard alert for Stryker spinal surgery device

Australia sounded the alarm on Stryker's (NYSE:SYK) Oasys Midline Occipital Plate, sending a warning to patients and surgeons that the spine stabilization device might break after surgery.

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.

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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."