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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 FirmOctober 25, 2019
Create DateDecember 12, 2019
Recall Status1 Terminated 3 on May 20, 2020
Recall NumberZ-0672-2020
Recall Event ID 84315
510(K)NumberK180906 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductiTotal 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/
Manufacturer
Conformis, Inc.
600 Technology Park Dr
Billerica MA 01821-4154
For Additional Information ContactSAME
781-345-9001
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
ActionConformis 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 Commerce1 unit
DistributionUS Nationwide distribution in the state of GA.
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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