Class 2 Device Recall APTUS Hand Scaphoid Plates

• Date Initiated by Firm: October 20, 2026
• Date Posted: November 12, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0433-2027
• Recall Event ID: 100171
• 510(K)Number: K234062
• Product Classification: Plate, fixation, bone - Product Code HRS
• Product: APTUS 1.2/1.5 TriLock Scaph.Pl 3x2H Large,t0.8, Model/Catalog Number: A-4350.81; APTUS fixation systems are intended for temporary fixation, correction or stabilization of bones
• Code Information: UDI DI/GTIN: 07630894811647, Lot Number 26508730
• FEI Number: 3003236702
• Recalling Firm/ Manufacturer: Medartis AG; Hochbergerstrasse 60e; Basel Town Switzerland
• For Additional Information Contact: Ms. Carmen Mangel; 41-61-6333723
• Manufacturer Reason for Recall: Plate is incorrectly bent
• FDA Determined Cause: Process control
• Action: Medartis issued an Urgent Medical Device RECALL notice to its consignees on 10/20/2026 via email. The notice explained the issue, potential risk, and requested the following: Scenario (Packaged product): Identify affected plates A-4350.81, lot 26508730, cease use and place them in quarantine for return them to Medartis Inc. (Indiana, USA), contacting Medartis before shipping to receive return instructions. Scenario B (Plates in containers): Because the lot number is not directly marked on the plate, inspect every A-4350.81 plate in their containers for the bend direction, as shown in the pictures in the notification. Correctly bent plates may remain in the container. Wrongly bent plates, or plates where they are in doubt, must be quarantined and returned to Medartis Inc. for replacement. All customers: Forward the notification to all relevant users within their organization and to any organization the affected devices were transferred to. Complete and return the customer reply form within 14 calendar days of receipt, even if they no longer have any affected devices.
• Quantity in Commerce: 65 units
• Distribution: US Nationwide distribution in the states of IN, AZ, CA, NY.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = HRS