• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall 3D Knee Tibial InsertDCM

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall 3D Knee Tibial InsertDCM see related information
Date Initiated by Firm March 19, 2010
Date Posted April 26, 2010
Recall Status1 Terminated 3 on July 22, 2010
Recall Number Z-1433-2010
Recall Event ID 55171
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/
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
Manufacturer Reason
for Recall
Affected product had incorrect color label which is a secondary visual indicator for sizing.
FDA Determined
Cause 2
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 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 = ENCORE ORTHOPEDICS, INC.