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U.S. Department of Health and Human Services

Class 2 Device Recall The iTotal PS Knee Replacement System

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  Class 2 Device Recall The iTotal PS Knee Replacement System see related information
Date Initiated by Firm October 31, 2016
Date Posted January 10, 2017
Recall Status1 Terminated 3 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
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/
ConforMIS, Inc.
28 Crosby Dr
Bedford MA 01730-1402
For Additional Information Contact SAME
Manufacturer Reason
for Recall
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
FDA Determined
Cause 2
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 and Original Applicant = CONFORMIS, INC.