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U.S. Department of Health and Human Services

Class 2 Device Recall The GMK knee system

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  Class 2 Device Recall The GMK knee system see related information
Date Initiated by Firm October 24, 2017
Date Posted December 20, 2017
Recall Status1 Open3, Classified
Recall Number Z-0266-2018
Recall Event ID 78401
510(K)Number K090988  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
Code Information all serial numbers
Recalling Firm/
Manufacturer
Medacta Usa Inc
3973 Delp St
Memphis TN 38118-6110
For Additional Information Contact Customer Service
312-878-2381
Manufacturer Reason
for Recall
Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.
FDA Determined
Cause 2
Device Design
Action All surgeon customers shall be notified via email by October 24, 2017 of the reminder to follow the surgical technique. To ensure that surgeons receive the notification, we will send the letter via email so that we can track and ensure the message was received. If the email is returned, we would then send a personalized letter directly to the surgeon. A copy of this notification is included with the submission of this report.
Quantity in Commerce 12,768 units
Distribution nationwide
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = MEDACTA INTERNATIONAL, SA
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