Z-1549-2026Class II

Medartis AG

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Medartis AG

Product type

Device

Status

Ongoing

Report date

2026-03-18

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.

Firm state

N/A

Product quantity

Initiated by

Voluntary: Firm initiated

Reason for recall

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

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.

Code / lot info

Lot Code: Version or Model: A-5750.16/1 Device Description: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25472432

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →