Stryker’s recent recall of its Midline Occiput Plate has been assigned the FDA’s most serious Class 1 label. This indicates that a malfunctioning component of the spinal surgery device could possibly have fatal consequences.
Stryker initiated the recall in May, after reports that the pin that connects the implant’s tulip head to the plate body can fracture, potentially causing blood loss, nerve injury and the need for surgery to replace the fractured implant. Stryker made an announcement urging medical facilities to examine inventory and immediately stop distributing or using the recalled device.
In a June 20th notification to spinal implant surgeons, Stryker recommended that they conduct routine clinical and radiographic post-operative evaluations on patients with the implanted device. They advised that particular attention should be given to those experiencing pain, weakness or numbness.
Source: Outpatient Surgery Magazine