Medartis APTUS 2.8 TriLock Screw recalled for size mix-up
Medartis discovered that certain packages labeled as 2.8mm APTUS TriLock Screws may actually contain 2.5mm screws instead. This size mix-up could affect surgical fixation in hand, forearm, shoulder, or foot procedures. The issue affects 126 units distributed in the US (Indiana and Pennsylvania) and 12 European and other countries.
From the FDA notice · Read the official notice ↗
What to do
- Check if you have APTUS 2.8 TriLock Screw 16mm (Model A-5850.16/1) with lot code 25467933
- Do not use affected screws until you verify the screw size
- Contact Medartis or your supplier to confirm the screw diameter before implantation
- Contact your local FDA office or Medartis if you have already used screws from this lot
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- All ages (under 120 years)
This recall covers 2 products — see all of them.
Details
- Units affected
- 126
- Illnesses reported
- None reported
- Manufactured in
- Hochbergerstrasse 60e, N/A, Basel Town, N/A, Switzerland
- Classification
- Class II
- Recall number
- Z-1550-2026
In the FDA's words
- Description
- 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. Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws. Lot Code: Version or Model: A-5850.16/1 Device Description: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25467933 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: 126
- 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…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… (this page)Z-1550-2026 · 126