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
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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/ Manufacturer |
Conformis, Inc. 600 Technology Park Dr Billerica MA 01821-4154
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For Additional Information Contact | SAME 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 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = JWH
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