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U.S. Department of Health and Human Services

Class 2 Device Recall 3D Knee Tibial InsertDCM

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 Class 2 Recall
3D Knee Tibial InsertDCM
see related information
Date Posted April 26, 2010
Recall Status1 Terminated on July 22, 2010
Recall Number Z-1433-2010
Recall Event ID 55171
Premarket Notification
510(K) Number
K020114 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product 3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee pain and restoring knee joint function.
Code Information Catalog Number: 392-11-604, Lot Number: 59600085.
Recalling Firm/
Manufacturer
Encore Medical, Lp
9800 Metric Blvd
Austin, Texas 78758
Manufacturer Reason
for Recall
Affected product had incorrect color label which is a secondary visual indicator for sizing.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Encore Medical, LP notified consignees by e-mail dated March 19, 2010. Consignees were requested to return the affected product to the firm. For further information, contact Encore Medical, LP at 1-888-838-3668.
Quantity in Commerce 7 units
Distribution Worldwide Distribution -- United States (UT, IA) and Germany.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ENCORE ORTHOPEDICS, INC.
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