Medartis APTUS 2.5 TriLock Screw recalled for size mix-up risk
Medartis AG recalled specific lots of APTUS 2.5 TriLock Screws used in hand, forearm, shoulder, and foot surgery because some packages may contain 2.8mm screws instead of the labeled 2.5mm size. Using the wrong size screw could affect surgical fixation.
From the FDA notice · Read the official notice ↗
What to do
- If you have lot 25472432, verify the screw size before use
- Contact Medartis or your surgical supplier if you have affected screws
- Do not use screws from this lot if the size cannot be confirmed
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 0
- Illnesses reported
- None reported
- Manufactured in
- Hochbergerstrasse 60e, N/A, Basel Town, N/A, Switzerland
- Classification
- Class II
- Recall number
- Z-1549-2026
In the FDA's words
- 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. Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. Lot Code: Version or Model: A-5750.16/1 Device Description: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25472432 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. Affected quantity: 0
- Hazard
- Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
2 products in this recall
The agency lists each product separately. Check every one you might have.
- 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 Descriptio… (this page)Z-1549-2026 · 0
- 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 Descriptio…Z-1550-2026 · 126