FDA Issues Class 1 Recall for Stryker’s OASYS Due to Defect

The U.S. Food and Drug Administration (FDA) issued a Class 1 recall, which is the most serious of all recall classes, for the Stryker OASYS Midline Occiput Plate, used in cervical spinal fusion surgery, following reports of post-operative fracture of a key piece of the device.

The FDA posted an August 29 safety alert to inform the public of a Class 1 recall of Stryker’s OASYS Midline Occiput Plate, based on reports that following surgery, the pin that connects the tulip head to the plate body can break. Such a fracture could possibly lead to destabilization of the plate, requiring revision surgery, the FDA warned in the safety alert.

Patients who are implanted with this device have the possibility of serious adverse health risks, including blood loss and nerve injury, in addition to the possible need for revision surgery to replace the fractured implant, according to the FDA’s safety alert.

Class 1 recalls are the most serious and involve situations where 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 experiencing symptoms including pain, weakness or numbness, urgent evaluation is needed, according to the FDA’s safety alert, adding that for patients who have undergone revision surgery, Stryker recommends routine post-operative care and follow-up.

On May 30, 2013, Stryker issued an Urgent Device Recall requesting medical facilities to examine their inventory and immediately stop distributing or using the recalled lots.  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.

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.

On July 22, the Australian Governments Department of Health and Aging issued a hazard alert regarding the OASYS Midline Occipital Plate.

Feel free to contact one of our Gacovino Lake attorneys for more information at 1-800-246-HURT (4878).

Related Posts