Class 2 Device Recall Aesculap Arcadius Trial Insertion Instrument (ME020R/ME020RUS)

• Date Initiated by Firm: September 20, 2013
• Date Posted: November 19, 2013
• Recall Status: Terminated on December 16, 2014
• Recall Number: Z-0361-2014
• Recall Event ID: 66534
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
• Code Information: model no. ME020R
• FEI Number: 2916714
• Recalling Firm/ Manufacturer: Aesculap, Inc.; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: Customer Support; 800-258-1946 Ext. 5067
• Manufacturer Reason for Recall: The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserter shaft block area located near the thumb wheel.
• FDA Determined Cause: Device Design
• Action: An Important Product Removal Notification dated September 20, 2013 was sent to customers.
• Quantity in Commerce: 30
• Distribution: Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.