Recall Z-2361-2026— Medartis AG

Name: FDA recall Z-2361-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-24

Class II · Ongoing

Class II FDA medical device recall by Medartis AG, initiated 2026-04-24. It names one FDA 510(k) clearance: K202589. Product: Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation. Reason: The cannulation of the CCS screw is not centered..

Recalling firm: Medartis AG
Classification: Class II
Status: Ongoing
Initiated: 2026-04-24
Firm location: Basel Town, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K202589 — APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire SystemMedartis AG·cleared 2020-11-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

The cannulation of the CCS screw is not centered.

Data sourced from openFDA. This site is unofficial and independent of the FDA.