FDA-Device2026-03-18Class IIMISBRANDING
Medartis APTUS 2.8 TriLock Screw recalled for size mix-up
LABEL MIX UPNationwide distribution
Check Medartis APTUS screw lot 25467933
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.
- 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
Hazard
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Sold states
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 count
126
Manufactured in
Hochbergerstrasse 60e, N/A, Basel Town, N/A, Switzerland
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1550-2026More Medartis AG recalls
- FDA-Device2026-03-18Medartis APTUS 2.5 TriLock Screw recalled for size mix-up risk
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