Medartis AG is undergoing a Class II recall initiated by the FDA for its APTUS 2.5 TriLock Screw (Model/Catalog Number: A-5750.16/1). The recall stems from a mix-up between specified lots of 2.5mm and 2.8mm outer diameter screws. The affected product has seen worldwide distribution, including nationwide in Indiana and Pennsylvania, as well as in Austria, Belgium, Switzerland, and the Czech Republic.

Healthcare providers and distributors who have received the affected product should immediately identify and quarantine the specified lots to prevent patient harm. The company is coordinating with regulatory authorities to manage the recall process. While specific actions for affected entities are not detailed in this notice, prompt identification and segregation of the mixed-up screw lots are critical to avoid potential patient injury or incorrect surgical outcomes.