Class 2 Device Recall Hintermann Series H3 Total Ankle Replacement Prosthesis

• Date Initiated by Firm: September 25, 2018
• Create Date: November 07, 2018
• Recall Status: Terminated on December 05, 2019
• Recall Number: Z-0403-2019
• Recall Event ID: 81293
• Product Classification: Prosthesis, Ankle, Uncemented, Non-Constrained - Product Code NTG
• Product: DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
• Code Information: Lot: AAAEM
• FEI Number: 3012104767
• Recalling Firm/ Manufacturer: DT MedTech, LLC; 110 West Rd Ste 227; Towson MD 21204-2341
• Manufacturer Reason for Recall: Incorrect package labeling identifying the device
• FDA Determined Cause: Packaging process control
• Action: DT Med Tech LLC initially notified accounts by email notification on 9/25/18 followed by notification letter; The letters explain the process for the identification and return to HealthLink BV (distribution warehouse in The Netherlands) of the products affected (lot AAADP/AAAEM).
• Quantity in Commerce: 1
• Distribution: Australia, Ireland, Korea, Germany
• 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.