FDA-Device2026-03-18Class II

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.

Medartis AG

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1550-2026

Original summary

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

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