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.
FDA Recall Z-1550-2026 · Posted 2026-03-10
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Recalling FirmMedartis AG
Recall StatusOpen, Classified
Product CodeHWC
Date Initiated2026-01-09
Product Quantity126
Reason for Recall
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Firm Action
Firm began notifying affected customers on January 13, 2026 via email. Customers were instructed to return impacted products to Medartis Inc.
Root Cause
Labeling mix-ups
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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