FDA Announces Class I Recall of Stryker Spine Oasys Midline Occiput PlateSep 3, 2013
Stryker Spine, based in Allendale, New Jersey, has issued a recall of its Oasys Midline Occiput Plate, which is part of the Oasys Occipito-Cervico-Thoracic System used in spinal fusion surgery. A pin connecting the tulip head to the plate body may fracture, causing serious health consequences.
Stryker initiated the recall after reports of post-operative fracture of the pin, which can lead to adverse health consequences including blood loss and nerve injury. Patients may need revision surgery to replace the fractured implant. The Oasys Midline Occiput Plate provides stabilization at the junction between the occipital bone (at the base of the skull) and the vertebrae in the cervical spine.
The affected products were distributed from April 23, 2010, through February 12, 2012. The product codes for the five different plate sizes are 48551044, 48551045, 48551046, 48551046, and 48551047.
In May, Stryker issued an Urgent Medical Device Recall requesting medical facilities to examine their inventory and immediately stop distributing or using the recalled lots. Medical facilities should return affected products to Stryker. In June Stryker contacted spinal implant surgeons recommending routine clinical and radiographic post-operative evaluation for patients with implanted Oasys Midline plates. An urgent evaluation is needed if a patient experiences pain, weakness, or numbness.
This is a Class I recall, the U.S. Food and Drug Administration (FDA)’s most serious recall category, reserved for situations in which there is a “reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.
Health care professionals and consumers are encouraged to report adverse reactions or quality problems with these products to the FDA through the MedWatch reporting program.