FDA Says Recalled Stryker Device is Potentially Deadly
Spinal implant recall is now Class 1.
Published: August 30, 2013
The FDA has assigned its most serious label, Class 1, to Stryker's recall of its Midline Occiput Plate, indicating that a malfunctioning component of the spinal surgery device could have deadly 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. In its announcement, Stryker urged medical facilities to examine inventory and immediately stop distributing or using the recalled device.
In a June 20 notification to spinal implant surgeons, Stryker recommended that they conduct routine clinical and radiographic post-operative evaluations on patients with the implanted device, with particular attention to those experiencing pain, weakness or numbness.
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