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U.S. Department of Health and Human Services

Class 2 Device Recall Conformis, Inc.

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  Class 2 Device Recall Conformis, Inc. see related information
Date Initiated by Firm October 25, 2019
Create Date December 12, 2019
Recall Status1 Terminated 3 on May 20, 2020
Recall Number Z-0672-2020
Recall Event ID 84315
510(K)Number K180906  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product iTotal CR Knee Replacement System
Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR 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: 0450585
Recalling Firm/
Conformis, Inc.
600 Technology Park Dr
Billerica MA 01821-4154
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
FDA Determined
Cause 2
Under Investigation by firm
Action Conformis contacted surgeon via phone on 10/16/19 with the replacement details. Replacement inserts that match the implanted tibial tray interlock geometry were shipped to the affected customer.
Quantity in Commerce 1 unit
Distribution US Nationwide distribution in the state of GA.
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.