A Class I recall was recently issued for Stryker Spine’s OASYS Midline Occiput Plate warning patients and physicians that the device is at risk for fracture. According to the FDA, the recall affects products that were distributed from April 23, 2010 through February 12, 2013. The OASYS Midline Occiput Plate is part of the OASYS Occipito-Cervico-Thoracic System and was used in fusions of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3). The OASYS Midline Occiput Plate was originally designed to provide stabilization at the junction between the occipital bone and the vertebrae in the cervical spine.
Over the last several months Stryker has received numerous reports indicating post-operative fracture of the pin that connects the tulip head to the plate body. In May of this year the company first issued a recall, warning of serious health consequences including blood loss and nerve damage. Then, in June, Stryker notified spinal implant surgeons that it is recommending routine clinical and radiographic post-operative evaluation for patients with an implanted OASYS Midline Plates, and that those experiencing pain, weakness, or numbness may require revision surgery to replace the fractured implant.
It is important to remember that a Class I Recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these recalled products will cause serious adverse health consequences or death. If you or a loved one has been implanted with and injured by the Stryker OASYS Midline Occiput Plate it is important you contact your physician as soon as possible. Additionally, you should take action to secure the compensation you need and ensure that the responsible parties are held accountable for any harm done to you or a loved one. The lawyers at Suthers & Harper have years of experience litigating defective medical device cases. Suthers & Harper is currently investigating cases on behalf of individuals who were injured after being surgically implanted with Stryker’s Spine OASYS Midline Occiput Plate. To discuss a potential lawsuit for yourself, a family member or friend, call 1-800-320-2384 or go to www.sutherslaw.com for a free Stryker lawsuit consultation.