Class 2 Device Recall iTotal Posterior Stabilized (PS) Knee Replacement System

• Date Initiated by Firm: January 04, 2019
• Create Date: March 30, 2019
• Recall Status: Terminated on June 29, 2020
• Recall Number: Z-1079-2019
• Recall Event ID: 82101
• 510(K)Number: K161668
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
• Code Information: Serial Numbers 0434436 and 0434836
• Recalling Firm/ Manufacturer: Conformis, Inc.; 600 Technology Park Dr; Billerica MA 01821-4154
• For Additional Information Contact: Tom Haueter; 781-345-9161
• Manufacturer Reason for Recall: The labeling of the boxes and sterile pouches did not match the contents.
• FDA Determined Cause: Employee error
• Action: Emails were sent to the customers on 1/4/19 requesting return of the affected products.
• Quantity in Commerce: 2
• Distribution: The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: 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.

• 510(K) Database: 510(K)s with Product Code = JWH and Original Applicant = CONFORMIS, INC.