Class 3 Device Recall Foundation

• Date Initiated by Firm: May 10, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated 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
• FEI Number: 1000116912
• Recalling Firm/ Manufacturer: 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: Other
• 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