Stryker recalls a spine implant, gets ‘Deadly’ FDA Label
Stryker Recalls Spinal Implant, Gets ‘Deadly’ FDA Label (OrthoSpineNews)
Stryker (download 4-page analysis of Stryker HERE) is recalling lots of a device used in spinal surgeries, and the FDA has assigned its most serious tag to the problem, warning that using the device could result in serious injury or death.
At issue is the Oasys Occipito-Cervico-Thoracic System, a device designed to stabilize the junction between the occipital bone and vertebrae in the cervical spine. Stryker has received reports that a pin that connects the tulip head to the plate body can fracture, possibly causing blood loss, nerve injury and the need for revision surgery. The FDA put its Class I designation on the recall, a label reserved for potentially deadly malfunctions.
Stryker initiated the recall in May, warning customers to stop using the affected lots and ship them back to the company. In June, Stryker put out a note urging surgeons to conduct routine post-op evaluations on patients who already have Oasys implants, keeping an eye out for symptoms that may require revision procedures.
Today, the company released a statement explaining the timeline of the recall but isn’t commenting on how many implants are affected or how much it expects the action to cost.
And speaking of costs, Stryker is no stranger to forking over legal fees and settlements related to problematic implants. Last year’s recalls of the Rejuvenate and ABG II hip implants have forced the devicemaker to pay more than $400 million and counting to cover lawsuits and revision surgeries, already $10 million more than the worst-case scenario CEO Kevin Lobo forecast back in January.
Those charges have wiped away profit gains for three straight quarters, and the company hasn’t said when it expects to get out from under the issue. In Q2, $170 million in recall-related charges stole headlines from Stryker’s 5% sales growth, as the Michigan devicemaker posted revenue gains in each of its three segments.