Access Now: AORN COVID-19 Clinical Support

Home >  News >  August, 2013

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.

Jim Burger

Also in the News...

APIC Survey Reveals Depth of PPE Shortages
COVID-19 Call to Action
Virtual OR Excellence Still Going Strong
Lessons Learned During the Pandemic
Handle Workplace Legal Issues Like a Pro
The Secret to Safer Surgery
Remember Why You Work in Surgery

New to Outpatient Surgery Magazine?
Sign-up to continue reading this article.
Register Now
Have an account? Please log in:
Email Address:
  Remember my login on this computer

advertiser banner

Other Articles That May Interest You