Washington, DC: The US Food and Drug Administration (FDA) and Stryker have notified healthcare professionals of a class 1 recall of the Stryker Spine: OASYS Midline Occiput Plate. Stryker has received reports indicating post-operative fracture of the pin that connects the tulip head to the plate body. This may cause serious adverse health consequences including blood loss, nerve injury, and the need for revision surgery to replace the fractured implant. Patients may experience symptoms including pain, weakness, or numbness.
The OASYS Midline Occiput Plate is part of the OASYS Occipito-Cervico-Thoracic System used to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput ??" T3). The OASYS Midline Occiput Plate provides stabilization at the junction between the occipital bone and the vertebrae in the cervical spine.
The affected products were distributed from April 23, 2010, through February 12, 2013.
On May 30, 2013, Stryker issued an Urgent Medical Device Recall requesting medical facilities to examine their inventory and immediately stop distributing or using the recalled lots. If a medical facility has the affected product in stock, it should be returned to Stryker.
On June 20, 2013, Stryker notified spinal implant surgeons recommending routine clinical and radiographic post-operative evaluation for patients with an implanted OASYS Midline plate.