Date Initiated by Firm |
January 28, 2016 |
Create Date |
October 02, 2018 |
Recall Status1 |
Terminated 3 on March 09, 2016 |
Recall Number |
Z-1070-2016 |
Recall Event ID |
73246 |
510(K)Number |
K142161
|
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product |
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111 |
Code Information |
Serial Number:0363410 UDI - M572TCR1111111021/$$316073103634108 |
Recalling Firm/ Manufacturer |
ConforMIS, Inc. 28 Crosby Dr Bedford MA 01730-1402
|
For Additional Information Contact |
SAME 781-345-9001
|
Manufacturer Reason for Recall |
Incorrect femoral component distributed
|
FDA Determined Cause 2 |
Packaging process control |
Action |
Conformis notiifed the surgeon via the sales rep on 1/28/16 of the error and the correct femoral component was processed. The surgeon received it on February 1, 2016. |
Quantity in Commerce |
1 unit |
Distribution |
KY |
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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JWH and Original Applicant = CONFORMIS, INC.
|