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 impla...
