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U.S. Department of Health and Human Services

Class 2 Device Recall APTUS 2.5 TriLock Screws and APTUS 2.8 TriLock Screws

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 Class 2 Device Recall APTUS 2.5 TriLock Screws and APTUS 2.8 TriLock Screwssee related information
Date Initiated by FirmJanuary 09, 2026
Date PostedMarch 10, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1550-2026
Recall Event ID 98353
510(K)NumberK091479 
Product Classification Screw, fixation, bone - Product Code HWC
ProductBrand 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.
Code Information Lot Code: Version or Model: A-5850.16/1 Device Description: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Lot: 25467933
FEI Number 3003236702
Recalling Firm/
Manufacturer		 Medartis AG
Hochbergerstrasse 60e
Basel Town Switzerland
For Additional Information ContactMr. Mario Kegler
0041-61-6333797
Manufacturer Reason
for Recall		Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
FDA Determined
Cause 2		Labeling mix-ups
ActionFirm began notifying affected customers on January 13, 2026 via email. Customers were instructed to return impacted products to Medartis Inc.
Quantity in Commerce126
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HWC
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