Class 2 Device Recall Conformis iTotal CR Knee Replacement System

• Date Initiated by Firm: January 28, 2016
• Create Date: October 02, 2018
• Recall Status: Terminated on March 09, 2016
• Recall Number: Z-1070-2016
• Recall Event ID: 73246
• 510(K)Number: K142161
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
• Code Information: Serial Number:0363410 UDI - M572TCR1111111021/$$316073103634108
• Recalling Firm/ Manufacturer: ConforMIS, Inc.; 28 Crosby Dr; Bedford MA 01730-1402
• For Additional Information Contact: SAME; 781-345-9001
• Manufacturer Reason for Recall: Incorrect femoral component distributed
• FDA Determined Cause: Packaging process control
• Action: Conformis notiifed the surgeon via the sales rep on 1/28/16 of the error and the correct femoral component was processed. The surgeon received it on February 1, 2016.
• Quantity in Commerce: 1 unit
• Distribution: KY
• 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.

• 510(K) Database: 510(K)s with Product Code = JWH