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U.S. Department of Health and Human Services

Class 2 Device Recall Confmsi I Total

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  Class 2 Device Recall Confmsi I Total see related information
Date Initiated by Firm July 20, 2020
Create Date August 22, 2020
Recall Status1 Completed
Recall Number Z-2849-2020
Recall Event ID 86174
510(K)Number K180906  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant
Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Code Information Serial Number: 0469247 Exp. 2021-01-31
Recalling Firm/
Manufacturer
Conformis, Inc.
600 Technology Park Dr
Billerica MA 01821-4154
For Additional Information Contact SAME
781-345-9001
Manufacturer Reason
for Recall
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
FDA Determined
Cause 2
Packaging process control
Action Conformis notification to field sales representative on July 20,2020 to remove product from use.
Quantity in Commerce 1 kit
Distribution NV
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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = Conformis, Inc.
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