Class 2 Device Recall Foundation Total Knee System.

• Date Initiated by Firm: November 03, 2005
• Date Posted: December 29, 2005
• Recall Status: Terminated on April 04, 2008
• Recall Number: Z-0331-06
• Recall Event ID: 33991
• 510(K)Number: K923277
• Product Classification: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
• Product: Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement.
• Code Information: Lot #426142 and #426132.
• Recalling Firm/ Manufacturer: Encore Medical, Lp; 9800 Metric Blvd; Austin TX 78758
• Manufacturer Reason for Recall: The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.
• FDA Determined Cause: Other
• Action: Firm initiated recall on 11/03/05 via letter to all consignees.
• Quantity in Commerce: 16 units.
• Distribution: Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, 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