The U.S. Food and Drug Administration (FDA) hit Allendale, NJ-based Stryker’s Spine division with a Class I recall for the company’s OASYS Midline Occiput Plate.
According to reports, Stryker learned that a post-operative fracture can occur in the pin that connects the tulip head to the plate body. The scenario could cause serious adverse health consequences, including blood loss, nerve injury, and the need for revision surgery to replace the fractured implant.
Class I recalls are reserved for such situations in which there is a reasonable probability that the product will cause serious adverse health consequences or death.
The plate is part of the OASYS Occipito-Cervico-Thoracic System that is used to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3). The plate provides stabilization at the junction between the occipital bone and the vertebrae in the cervical spine.
The affected products (listed below) were distributed from April 23, 2010 through February 12, 2013. Currently, 1,536 units are in commerce in the U.S. with another 880 abroad.