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U.S. Department of Health and Human Services

Class 2 Device Recall Foundation Porous Coated Hip Stem

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 Class 2 Device Recall Foundation Porous Coated Hip Stemsee related information
Date Initiated by FirmJune 30, 2004
Date PostedJuly 22, 2004
Recall Status1 Terminated 3 on October 21, 2004
Recall NumberZ-1128-04
Recall Event ID 29537
510(K)NumberK993943 
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
ProductHA Hip Stem, cementless
Code Information Part number 470-02-090, Lot 938381
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
Manufacturer Reason
for Recall		Hip stem product was mis-labeled with wrong size.
FDA Determined
Cause 2		Other
ActionFirm sent letter of notification to consignee on 6/30/2004.
Quantity in Commerce3 units
DistributionDeerfield Beach, FL
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 = JDI
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