Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750...
FDA Recall #Z-1549-2026 — Class II — January 9, 2026
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.
Recalling Firm
Medartis AG — Basel Town, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
Worldwide - US Nationwide distribution in the states of Indiana and Pennsylvania and the countries of Austria, Belgium, Switzerland, Czech Republic, Germany, Spain, Finland, France, Israel, Italy, Japan, and Poland.
Code Information
Lot Code: Version or Model: A-5750.16/1 Device Description: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25472432
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated