FDA: Recalled Stryker Device is Potentially Deadly
The U.S. Food and Drug Administration (FDA) has assigned its most serious label, Class 1, to Stryker Corporation's recall of its Midline Occiput Plate, indicating that a malfunctioning component of the spinal surgery device could have deadly consequences.
The Australian Department of Health and Ageing Therapeutic Goods Association also has partnered with Stryker Australia to announce a hazard alert for the plate.
Stryker initiated the recall in May, after reports that the pin connecting the implant's tulip head to the plate body can fracture, potentially causing blood loss, nerve injury and possibly revision surgery to replace the fractured implant. In its announcement, Stryker advised medical facilities to examine inventory for Oasys implants manufactured between April 23, 2010, and Feb. 12, 2013, and return them to the company. The following month, Stryker urged surgeons to conduct routine post-op evaluations on patients who received Oasys implants, and check for symptoms that indicate a need for revision procedures - namely pain, weakness or numbness.
On Aug. 29, the company released a statement explaining the timeline of the recall but remained mum on the potential number of affected implants.
"Stryker's Spine division recently received notice that the U.S. Food and Drug Administration has reviewed the voluntary recall of its Oasys Midline Occiput Plate (Small, Medium, Large, Large Long, Mini) and that it will be classified as a Class I recall,"the company's official statement reads. "In February 2013, Stryker Spine instructed all U.S. registered Oasys System surgeon users to discontinue use and ordering of the Oasys Midline Occiput Plate and in May 2013 voluntarily recalled the product. These actions were taken after Stryker received reports of a fracture of the pin on the midline plate. This issue was identified through standard post-market surveillance of product complaints. A Product Notification was issued to surgeons and hospital risk managers which described the known hazards and harms potentially associated with the use of the affected products. As stated in the February 2013 Product Notification, Stryker recommended that patient follow-up beyond the routine standard of care was not necessary."
Released in 2010, the Oasys Occipito-Cervico-Thoracic System is a device designed to stabilize the junction between the occipital bone and vertebrae in the cervical spine.
The Oasys recall is the second in two years to affect the Kalamazoo, Mich.-based orthopedic implant manufacturer. Last summer's recalls of the Rejuvenate and ABG II hip implants have forced the devicemaker to pay more than $400 million to cover lawsuits and revision surgeries, already $10 million more than the worst-case scenario CEO Kevin Lobo forecast back in January.
Those charges have wiped away profit gains for three straight quarters, and the company hasn't revealed a timeline for resolving the issue. In the second quarter, $170 million in recall-related charges stole headlines from Stryker's 5 percent sales growth, as the devicemaker posted revenue gains in each of its three segments.