Date Initiated by Firm |
November 19, 2014 |
Date Posted |
December 11, 2014 |
Recall Status1 |
Terminated 3 on October 08, 2015 |
Recall Number |
Z-0581-2015 |
Recall Event ID |
69867 |
510(K)Number |
K140423
|
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product |
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010
Intended for use as a total knee replacement in patients with knee joint pain and disability. |
Code Information |
Serial Number: 0340552 |
Recalling Firm/ Manufacturer |
ConforMIS, Inc. 28 Crosby Dr Bedford MA 01730-1402
|
For Additional Information Contact |
781-345-9001
|
Manufacturer Reason for Recall |
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
|
FDA Determined Cause 2 |
Labeling mix-ups |
Action |
Conformis notified the consignee by telephone on 11/19/14, about the problem. A sales representative visited the site and retrieved the device. |
Quantity in Commerce |
1 unit |
Distribution |
Distributed to IN. |
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.
|