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U.S. Department of Health and Human Services

Class 2 Device Recall Foundation Total Knee System.

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  Class 2 Device Recall Foundation Total Knee System. see related information
Date Initiated by Firm November 03, 2005
Date Posted December 29, 2005
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = ENCORE ORTHOPEDICS, INC.
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