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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall iTotal Posterior Stabilized (PS) Knee Replacement System see related information
Date Initiated by Firm January 04, 2019
Create Date March 30, 2019
Recall Status1 Terminated 3 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/
Conformis, Inc.
600 Technology Park Dr
Billerica MA 01821-4154
For Additional Information Contact Tom Haueter
Manufacturer Reason
for Recall
The labeling of the boxes and sterile pouches did not match the contents.
FDA Determined
Cause 2
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.