Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm recall (Medartis AG)
Medical deviceClass IIOngoing
Summary: Medartis AG is recalling 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 appl. Reason: Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
What is being recalled
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.
Why
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Indiana, Pennsylvania)
How to tell if yours is affected
Lot Code: Version or Model: A-5750.16/1 Device Description: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25472432
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1549-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 9, 2026 |
| Reported | March 18, 2026 |
| Company | Medartis AG |
| Company location | Basel Town, N/A, Switzerland |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 0 |
More recalls from Medartis AG · all medical device recalls · recalls from January 2026