|Fda (Photo credit: Wikipedia)|
The U.S. Food and Drug Administration (FDA) has issued a class one (1) recall on the Stryker Spine OASYS Midline Occiput Plate. The plate is commonly used as an implant in spinal surgeries. The failure of these implants can cause serious side effects such as blood loss, nerve injury and a need for revision surgery.
Class I recalls are the most serious – involving situations “in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” the FDA reported in the safety alert. If a patient begins suffering from symptoms such as pain, weakness, or numbness, “urgent evaluation is needed,”
In the FDA’s initial recall announcement of the product, issued on May 30, 2013, it noted that the Oasys Midline Occiput Plate is part of the Oasys System, which is used in spinal surgery to promote fusion and provide stabilization at the junction between the occipital bone and the vertebrae in the cervical and thoracic spine.
The Products made by Stryker that were reported to possibly have failures were distributed between April 23, 2010 and February 12, 2013. It is estimated the roughly 1300-1500 of the recalled plates may exist in the U.S. and another 880 internationally.
In 2009, Stryker recalled their Rejuvenate and ABG II modular-neck hip stems due to corrosion at the modular neck junctions. As a result of the failures, toxic metal debris may enter the soft tissue of the hip cavity or the blood stream. The Rejuvenate and ABG II recall has resulted in hundreds lawsuits and many expect the number to reach into the thousands.