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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 February 03, 2020
Create Date April 01, 2020
Recall Status1 Completed
Recall Number Z-1628-2020
Recall Event ID 85108
510(K)Number K161668  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) 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 0460018 0460118
Recalling Firm/
Manufacturer
Conformis, Inc.
600 Technology Park Dr
Billerica MA 01821-4154
For Additional Information Contact Kara Johnson
781-832-5402
Manufacturer Reason
for Recall
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
FDA Determined
Cause 2
Mixed-up of materials/components
Action Conformis Customer Service called three affected customers on February 4, 2020, to ask them to verify tibial tray serial numbers, and confirmed that the three kits in question had the incorrect tibial tray. These affected customers were asked to return the affected product to the firm. Following this action, Conformis Sales Representatives were instructed to verify that all products within their control, including those already placed in hospitals, that were manufactured between September 1, 2019, and February 3, 2020, had tibial tray serial numbers that matched the patient's serial number. No additional affected product was found in the field.
Quantity in Commerce 2
Distribution US Nationwide distribution in the states of LA, NY, TN.
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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