Class 2 Device Recall The iTotal PS Knee Replacement System

• Date Initiated by Firm: October 31, 2016
• Date Posted: January 10, 2017
• Recall Status: Terminated on January 11, 2017
• Recall Number: Z-0991-2017
• Recall Event ID: 75969
• 510(K)Number: K161668
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis
• Code Information: Serial Number: 0384180
• Recalling Firm/ Manufacturer: ConforMIS, Inc.; 28 Crosby Dr; Bedford MA 01730-1402
• For Additional Information Contact: SAME; 781-345-9001
• Manufacturer Reason for Recall: iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
• FDA Determined Cause: Software Design Change
• Action: ConForMIS intiated the recall by telephone on October 31, 2016, to the Sales Rep to request return of the kit. For questions regarding this recall call 781-345-9001.
• Quantity in Commerce: 1 unit
• Distribution: Distribution to TX only
• 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