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
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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
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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 |
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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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