Recall Z-1549-2026— Medartis AG

Name: FDA recall Z-1549-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-09

Class II · Ongoing

Class II FDA medical device recall by Medartis AG, initiated 2026-01-09. It names one FDA 510(k) clearance: K051567. Product: Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.. Reason: Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws..

Recalling firm: Medartis AG
Classification: Class II
Status: Ongoing
Initiated: 2026-01-09
Firm location: Basel Town, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K051567 — APTUS TITANIUM OSTEOSYNTHESIS SYSTEMMedartis, Inc.·cleared 2005-08-23

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

Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable.

Reason for recall

Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

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