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U.S. Department of Health and Human Services

Class 2 Device Recall iTotal Cruciate Retaining (CR) Knee Replacement System

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 Class 2 Device Recall iTotal Cruciate Retaining (CR) Knee Replacement Systemsee related information
Date Initiated by FirmFebruary 03, 2020
Create DateApril 01, 2020
Recall Status1 Terminated 3 on December 02, 2020
Recall NumberZ-1627-2020
Recall Event ID 85108
510(K)NumberK180906 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductiTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE 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 0454572 0454472 0459726 0449726
Recalling Firm/
Manufacturer		 Conformis, Inc.
600 Technology Park Dr
Billerica MA 01821-4154
For Additional Information ContactKara 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
ActionConformis 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 Commerce4
DistributionUS Nationwide distribution in the states of LA, NY, TN.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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