Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Stryker recall: Firm recalls 23 Navigation System II operating room surgical navigation systems with a faulty component that may result in the screen freezing, or the system updating at a slow rate or not responding at all, Stryker and FDA announced in November communications about the Class I recall. Navigation System II is a computer-aided surgery platform used in hip, knee, spine, neurological and ear, nose and throat procedures. Hospitals were advised to stop using the product, which Stryker is arranging to have repaired. All domestic units have been fixed, and there have been no reported injuries, the firm notes