FDAHealthJanuary 9, 2026
Medartis AG — Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems
⚠️ Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 9, 2026
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.
What's affected?
- Product
- Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 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.
- Brand
- Medartis AG
- Lot code
- Version
Additional details
Lot Code: Version or Model: A-5850.16/1 Device Description: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25467933
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 126.
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