Medartis AG recalls Medartis APTUS

The cannulation of the CCS screw is not centered.

Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation

Medartis issued an URGENT: Field Safety Notice - Recall to its consignees on 5/4/2026 via USPS. The notice explained the problem with the device, potential risks associated with its use, intraoperatively and postoperatively, and provided postoperative patient recommendations. Response to the Field Safety Notice should be made to: fieldaction.us@medartis.com or Medartis Inc., 1195 Polk Drive Warsaw, IN 46582. The device are to be returned.

• FDA enforcement recordOfficial FDA database entry for Z-2361-2026
• FDA 510(k) clearance · K202589The device's official FDA premarket clearance record
• FDA device classification · HWCOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3040The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medartis AGSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.