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U.S. Department of Health and Human Services

Class 3 Device Recall Foundation

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  Class 3 Device Recall Foundation see related information
Date Initiated by Firm May 10, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on August 09, 2004
Recall Number Z-1010-04
Recall Event ID 29130
510(K)Number K923277  
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758
Code Information Catalog number 324-01-106, Lot number 991151
Recalling Firm/
Encore Medical, LP
9800 Metric Blvd
Austin TX 78758
Manufacturer Reason
for Recall
Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE
FDA Determined
Cause 2
Action The firm sent recall letters to all consignees on May 10, 2004 requesting return of the product.
Quantity in Commerce 15
Distribution Product was distributed domesically to the following states: IA, MA, OK, TX, FL, CA, and SD. Product was shipped to one distributor in 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.