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U.S. Department of Health and Human Services

Class 2 Device Recall Foundation Knee System

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 Class 2 Device Recall Foundation Knee Systemsee related information
Date Initiated by FirmApril 24, 2003
Date PostedJuly 30, 2003
Recall Status1 Terminated 3 on July 29, 2003
Recall NumberZ-1069-03
Recall Event ID 26297
510(K)NumberK923277 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
ProductFoundation Knee System, non-porous Femur Size 8, Right
Code Information Lot numbers 811761, 815241, 815251, 817891, 834781, 835291, 838201, 850611
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758
Manufacturer Reason
for Recall		Product container was labeled incorrectly indicating left femur instead of right.
FDA Determined
Cause 2		Other
ActionThe firm recalled non-implanted devices. The firm initiated the recall on 04/23/2003 via phone to sales representatives and foreign distributors.
Quantity in Commerce14 unimplanted units
DistributionPA, TX, MA, FL, NV, AZ, and France and Saudi Arabia
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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