WhichRecall
Class IIReported 2026-03-18

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.

Recalled by Medartis AG

Reason for Recall

Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.

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Recall Number
Z-1549-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-01-09
Reported
2026-03-18
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.
Code Info
Lot Code: Version or Model: A-5750.16/1 Device Description: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25472432
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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