FDA Issues Class 1 Recall of Stryker OASYS Midline Occiput Plate Used in Spinal Surgery
On August 29, 2013, Stryker issued a recall of a device used in spinal surgery and the FDA designated the recall as a Class 1 recall, warning that the device failure could result in serious injury or death.
At issue is the OASYS Midline Occiput Plate, which is part of the OASYS Occipito Cervico Thoracic System used during spinal surgery to promote fusion of the cervical spine and occipito-cervico-thoracic junction. The Occiput Plate provides stabilization at the junction between the occipital bone and the vertebrae in the cervical spine. The recall was issued due to reports that a pin that connects the tulip head to the plate body can fracture possible causing blood loss, nerve injury, and the need for revision surgery to replace the fractured implant.
The recalled Stryker products were distributed from April 23, 2010 through February 12, 2013. The FDA recall recommends that if a patient begins experiencing symptoms including pain, weakness, or numbness, urgent evaluation is needed.
If you or a loved one has suffered injury or death as a result of the Stryker recall, our attorneys would be happy to review your records to determine whether you have a viable case. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.